NJ Bio, Inc._Careers

Careers

World ADC Best Contract Research Provider 2023
NJ Bio, Inc. is a rapidly growing quality contract research organization located In Princeton, NJ that provides chemistry and biopharmaceutical services specializing in bioconjugation, custom synthesis, bioassays, and process development. NJ Bio offers a competitive compensation and benefits package including 401(k), health, vision, dental, and life insurance plans.

NJ Bio is constantly expanding its team and is looking for dedicated and talented individuals.  We currently have the following job openings:

R&D - Bioconjugation

No Open Roles At This Time

 

R&D - Oligonucleotide Conjugation

No Open Roles At This Time

R&D - Molecular Biology/Protein Engineering/Cell Biology

No Open Roles At This Time

R&D - Chemistry

Director

Job Summary

Plan project responsibilities; plan work for each project and execute it towards a timeline while maintaining productivity; plan project execution of multiple chemical synthesis from milligrams to hundred of grams scales and their purification. Liaise with purchase to follow up on arrivals and help procurement with selection of materials; prepare and present project status and progress updates to clients; provide input on equipment purchases; get regular updates from project group; contribute to scientific discussions; check and maintain up to date lab notebooks for subordinates; supervise Scientists in R&D chemistry; maintain performance management metrics for personnel; be a subject matter expert for clients and stay abreast of current literature in scientific areas; write project reports containing procedures and experimental details for clients; maintain equipment, chemical inventory and participate in lab support activities. Perform other duties as required.

 

Job Responsibilities

  1. Plan work for each project and execute it towards a timeline while maintaining productivity.
  2. Plan project execution and purification of chemical synthesis from milligram to gram scale.
  3. liaise with purchase to follow up on arrivals and help procurement with selection of materials.
  4. Provide input on equipment purchases.
  5. Supervise and train subordinates; maintain performance management metrics for personnel.
  6. Review resumes, interview candidates and provide feedback to management.
  7. Assist with non-assigned project as needed.
  8. Be a subject matter expert for clients and stay abreast of current literature in scientific area.
  9. Get regular updates from project group and ensure quality and project timelines are being met.
  10. Check and maintain up to date lab notebooks for all subordinates.
  11. Prepare and present project status and progress updates to clients.
  12. Contribute to scientific discussions.
  13. Be a subject matter expert for the clients.
  14. Stay abreast of current literature in scientific areas.
  15. Write project reports containing procedures and experimental details for clients.
  16. Maintain equipment, chemical inventory, and participate in lab support activities.
  17. Complete mandatory assigned trainings.
  18. Perform duties as required.

 

Required Knowledge, Skills, and Abilities

  • Ability to effectively plan and execute projects.
  • Ability to effectively plan the work of others.
  • Ability to plan and execute work on multiple projects simultaneously.
  • Ability to supervisor and mentor others.
  • Ability to be an individual contributor.
  • Ability to perform work independently.
  • Ability to work collaboratively as part of a team.
  • Ability to communicate effectively, orally, in writing and to listen actively with internal and external stakeholders.
  • Ability to apply critical thinking and good problem-solving skills.
  • Ability to demonstrate a willingness to learn.

 


Job Specifications

Education and Experience Requirements

Ph.D. in chemistry or other related field with over 10 years industry experience or M.S. biochemistry, protein chemistry or other related field with 15 plus years’ experience.

Physical Demands

N/A

Working Conditions

Laboratory (majority of time will be spent in lab working on ongoing projects)
Office environment

Certificates & Licenses Required

N/A

 

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R&D - Project Management

No Open Roles At This Time

R&D - Process Development, Bioconjugation

Principal Scientist- Bioconjugation Process Development

Summary

Principal Scientist- Bioconjugation Process Development will lead the process development and production of ADCs as part of a multi-disciplinary team to advance ADC development and provide on-floor GMP support of manufacturing.

Responsibilities

  • Developing bioconjugation, purification, and UF/DF processes for use in first-in-human (FIH) GMP manufacturing of clinical candidates
  • Development and optimization of conjugation protocols utilizing novel chemistries and technologies
  • Represent the bioconjugation development group as a member of multidisciplinary project teams
  • Manage a team of bioconjugation scientists to meet project deliverables
  • Lead bioconjugation process development for the CMC team and will lead bioconjugation process development and technical transfer for manufacturing recombinant proteins.
  • Defining the approach to late-stage process characterization to define critical process parameters (CPPs) and processing ranges
  • Development and optimization of conjugation protocols utilizing novel chemistries and technologies

 

Qualifications

  • A Ph.D. in Biochemistry, Chemistry, or a related discipline with 10+ years of industrial experience is preferred
  • Qualified BS/MS candidates should have at least 15 years of industrial experience in a drug development setting
  • Candidates with previous experience in the development of ADCs, including hands-on experience with the development of conjugation, purification, and UF/DF processes, are preferred
  • Candidate should have experience with cGMP manufacturing, preferably in bioconjugation
  • Candidates with good working knowledge of analytical techniques, including HIC-, SEC-, RP-HPLC, and capillary electrophoresis, are preferred
  • Proven ability to collaborate effectively within cross-functional teams
  • Excellent analytical, communication, organizational, and presentation skills are essential
  • Subject Matter Expert in bioconjugation process development and manufacturing in support of CMC

 

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Manufacturing - Engineering

NJ Bio Inc is a growing chemistry and biotech CRO with laboratories located in Princeton, NJ and Bristol, PA. NJ Bio offers competitive salary, great benefits, and significant growth opportunities within the organization. NJ Bio is constantly expanding its team and is looking for dedicated and talented individuals. We currently have the following job openings in Process R&D, Chemistry department:

 

 

MSAT/Process Engineer – Various Levels

Job Summary
The MSAT/Process Engineer will support the GMP manufacturing of small molecules/ nucleic acids/ antibody conjugate with or without limited supervision and guidance. This role will collaborate effectively with personnel in Manufacturing, Engineering, Research and Development, Quality Assurance, and Quality Control utilizing strong communication, and technical expertise to maintain and improve manufacturing operations.

Key Responsibilities

  • Responsible to ensure chemical/bioprocessing equipment are ready for use when required
  • Identifies technical issues on chemical/bioprocessing equipment and recommends activities to resolve the issue. Identifies and implements procedures and activities to prevent the same issue from occurring.
  • Lead efforts in troubleshooting out-of-trend manufacturing processes, providing the intellectual, scientific and engineering leadership to identify and implement corrective actions.
  • Provides guidance and is accountable for determining the root causes of equipment and process related deviations in a timely and conclusive manner.
  • Ensures deep understanding of standards of practice, process science and departmental policies through participation in training and development opportunities.
  • Provides comprehensive training and guidance to operations staff.
  • Partner with Process Development to ensure successful process transfer.
  • Assist in equipment selection and design, qualification, and start up activities. Work with subject matter experts to ensure robust procedures are utilized for operation of equipment.
  • Work with the Validation team to develop and execute validation/qualification strategies.
  • Identify continuous improvement opportunities in terms of cost savings, process robustness, and manufacturing efficiency gains.


Required Knowledge, Skills, and Abilities

  • Able to communicate effectively in English, both verbally and in writing
  • Possess a positive roll-up-the-sleeves attitude and optimistic outlook.
  • Represents the organization in a positive and professional manner.
  • Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others.
  • Excellent organizational and time management skills with ability to set own priorities in a timely manner.
  • High degree of flexibility and adaptability
  • Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
  • Must be able to work as needed to meet tight deadlines and at peak periods.
  • Self-motivated and organized critical thinker with solid interpersonal and business communication skills.
  • Demonstrated ability to work in a cross functional team.
  • Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements.
  • Always observe safety precautions and regulations in all areas where duties are performed.
  • Responsible for reporting all safety hazards and potential unsafe working conditions.


Job Specifications

Education and Experience Requirements

  • BS in Chemical/Biochemical Engineering or other relevant discipline required.
  • MS in related discipline preferred.
  • Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, or process development required.
  • 3 – 10 years of relevant pharma or biotech industry experience, minimum 5 years GMP experience required.

Physical Demands
N/A

Working Conditions
Office environment with some lab/manufacturing environment

Certificates & Licenses Required
N/A

 

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Process R&D

No Open Roles At This Time

Quality Control

QC Scientist (IV, Senior, Principal)

The primary role of the QC Senior Scientist is to provide analytical support for GMP manufacturing and process development. The QC scientist will develop, qualify, and execute analytical test methods for raw materials, highly potent APIs, antibody-drug conjugates (ADCs), and other pharmaceutical products in a GMP setting.

Primary Responsibilities:  

  1. Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.
  2. Work with management and vendors to acquire, install, and qualify new equipment.
  3. Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
  4. Develop and execute analytical methods for small molecules, proteins, and antibody drug conjugates.
  5. Analysis of raw materials, in-process samples, finished products, and stability samples by various analytical instruments in a GMP compliant lab.
  6. Prepare standard operating procedures (SOPs), analytical test methods, protocols, reports, etc. as needed.
  7. Conduct OOS, risk assessment, and root cause investigations and/or assist management with these investigations.
  8. Write deviations, change controls, and CAPAs, and/or assist management with these documents.
  9. Document work in laboratory notebooks and logbooks according to organizational GDP policies.
  10. Write, review, and execute analytical protocols & reports for method transfers, qualifications, and validations in GMP setting.
  11. Manage work outsourced to third-party analytical and metrology service providers.
  12. Perform detailed peer review of analytical data to ensure accuracy.
  13. Train and oversee junior scientists.
  14. Expected to work independently or with minimal supervision.
  15. Expected to support in a lab maintain as per the SOPs.

Required Knowledge, Skills and Abilities  

  • Strong background in analytical sciences.
  • Ability to work independently and in a team setting.
  • Hands-on experience with various analytical techniques, including LC, GC, LC-MS, spectroscopy, electrophoresis, KF, endotoxin, ELISA, etc.

 

Education and Experience Requirements

  • BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
  • 5-10 years of experience in a GMP manufacturing or CRO setting.

 

Physical Demands

  • Typically requires standing and walking for entire shift.
  • Occasionally requires lifting of up to 20 pounds.
  • Frequently requires the use of a step stool.
  • Requires manual dexterity and visual abilities

 

Working Conditions

  • Laboratory and office environment

 

Certificates & Licenses Required

  • N/A

 

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Analytical Chemistry
NJ Bio Inc is a growing chemistry and biotech CRO with laboratories located in Princeton, NJ and Bristol, PA. NJ Bio offers competitive salary, great benefits, and significant growth opportunities within the organization. NJ Bio is constantly expanding its team and is looking for dedicated and talented individuals. We currently have the following job openings in Analytical Chemistry department:

 

 

Senior Scientist (Mass Spectrometry and cGMP experience)

Job Responsibilities

  • Independently develops mass spectroscopy methods for small molecules and/or large molecules characterization methods (QDa, QQQ, TOF & QTOF) and works on method optimization, troubleshooting, qualification, and validation.
  • Must be able to handle complex data interpretation software and perform statistical analyses on mass spectroscopy.
  • Must have worked in cGMP environment with mass specs.
  • May independently work on analytical method development, method optimization, troubleshooting, qualification, and validation in areas related to some or all the following: LC (SEC, RP, IEX, HIC etc.), capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods.
  • Participates in scientific discussions; stays abreast of current literatures in scientific areas; independently authors analytical test methods, protocols, and reports and other documents;
  • Orders supplies for client projects and may maintain certain lab equipment.
  • Performs duties as required.

 

Skills

  • Must have experience working on mass spectroscopy techniques (QDa, QQQ, TOF & QTOF), full knowledge of and practical experience with mass spectroscopy for small molecules and/or large molecules characterization methods in cGMP environment.
  • Must be able to independently develop, optimize, troubleshoot, qualify, and validate mass spec methods.
  • Hands-on working experience with analytical method development, optimization, troubleshooting, qualification, and validation of methods such as LC (SEC, RP, IEX, HIC etc.), capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods is a plus.
  • Work experience analyzing monoclonal antibodies (mAb’s), oligonucleotides, RNAs, and antibody drug conjugates (ADCs) is a huge plus.
  • Knowledge of control strategy for large molecules for drug substance and drug products, phase appropriate national and international regulatory filing strategies is preferred
  • Must be able to interpret data generated using complex data interpretation software and perform statistical analyses.
  • Training junior scientists and QC scientists on relevant assays and instruments.
  • Ability to plan and execute work on multiple projects simultaneously.
  • Ability to be an individual contributor and a collaborative team member
  • Ability to perform with minimal or no supervision
  • Ability to work collaboratively as part of a team
  • Ability to apply critical thinking and good problem-solving skills
  • Able to communicate scientific data effectively through presentations, protocols, test methods, and reports internally and externally
  • Maintain a culture of safety and ensure safe work practices within the lab
  • Adheres to company EHS and quality standards, regulations, and company policies, procedures, and mission
  • Communicates effectively with supervisors, colleagues, clients, and vendors

 

Education and Experience Requirements

  • Ph.D. in Analytical Chemistry, Organic chemistry, Biochemistry, or related areas with 2 – 4 years proven industry track record and experience directly relevant to the role is required, i.e., in analytical method development and problem solving in the pharmaceutical or biotech industry
  • or M.S. in Analytical Chemistry, organic Chemistry, Biochemistry, or related areas with 4-6 years proven industry track record and experience directly relevant to the role is required, i.e., in analytical method development and problem solving in the pharmaceutical or biotech industry

 

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Senior Scientist (HPLC and cGMP experience)

Job Responsibilities

  • Independently work on analytical method development, method optimization, troubleshooting, qualification, and validation in areas related to HPLC/UPLC (SEC, RP, IEX, HIC etc.), for analysis of small molecules and/ large molecules such as mAb’s, oligonucleotides, ADCs, OACs, mRNA etc.
  • Complex data interpretation, perform statistical analyses, summarize the results and effectively present data internally and externally.
  • Maintain and trouble shoot analytical instruments in GMP environment and working with vendors on routine maintenance and qualifications of the instruments.
  • Training junior scientists and QC scientists on relevant assays and instruments.
  • Participates in scientific discussions; stays abreast of current literatures in scientific areas; independently authors analytical test methods, protocols, and reports and other documents.
  • Orders supplies for client projects and may maintain certain lab equipment.
  • Performs duties as required.

 

Skills

  • Must have experience in developing, optimizing, troubleshooting, qualifying and validating HPLC methods (SEC, RP, IEX, HIC etc.), for small molecules and/or large molecules characterization in cGMP environment is required.
  • Hands-on working experience with mass spec, capillary electrophoresis (CZE), cIEF, GC, and other analytical instruments is a plus.
  • Work experience analyzing monoclonal antibodies (mAbs), oligonucleotides, RNAs, and antibody drug conjugates (ADCs) is a huge plus.
  • Knowledge of control strategy for large molecules drug substance and drug products, phase appropriate national and international regulatory filing strategies is preferred.
  • Must be able to interpret data generated, and able present results effectively.
  • Ability to plan and execute work on multiple projects simultaneously.
  • Ability to be an individual contributor and a collaborative team member.
  • Ability to perform with minimal.
  • Ability to apply critical thinking and good problem-solving skills.
  • Able to communicate scientific data effectively through presentations, protocols, test methods, and reports internally and externally.
  • Maintain a culture of safety and ensure safe work practices within the lab
  • Adheres to company EHS and quality standards, regulations, and company policies, procedures, and mission.
  • Communicates effectively with supervisors, colleagues, clients, and vendors.

 

Education and Experience Requirements

  • Ph.D. in Analytical Chemistry, Organic chemistry, Biochemistry, or related areas with 2 – 4 years proven industry track record and experience directly relevant to the role is required, i.e., in analytical method development and problem solving in the pharmaceutical or biotech industry.
  • M.S. in Analytical Chemistry, organic Chemistry, Biochemistry, or related areas with 4-6 years proven industry track record and experience directly relevant to the role is required, i.e., in analytical method development and problem solving in the pharmaceutical or biotech industry

 

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Senior Scientist, Bioanalytical Characterization

NJ Bio, Inc. is a rapidly growing chemistry and biotech CRO with laboratories in Princeton, NJ and Bristol, PA. NJ Bio offers competitive salaries, great benefits, and significant growth opportunities. NJ Bio is constantly looking to expand its team and looking for dedicated and talented individuals – NJ Bio is looking to hire a Senior Scientist in Bioanalytical for ADCs, large molecules.

Primary Responsibilities:  

  • Develop and perform cell-based assays in support of the client projects for mAb, ADCs, and mRNA vaccines.
  • Develop and optimize immunological and ligand binding assays, such as SPR, flow cytometry, immunoblot, and ELISA.
  • Analyze data, trouble-shoot experiments, and meet timelines.
  • Record experiments in notebook
  • Prepare results in PowerPoint or equivalent and present them in client meetings.
  • Summarize and communicate results to supervisor in a logical and effective manner.
  • Present data at meetings within the group or with external client meetings.
  • Write methods, protocols, and reports, and validate/qualify the methods.
  • Develop plate-based assays for process related residual impurities such as DNA, RNA, protein, etc.

 

Education Minimum Requirement:  

  • PhD in Biological Sciences such as Immunology, Virology, Cell Biology, Biochemistry, or related areas with 4+ years of relevant experience.
  • MS degree and 8+ years of relevant experience will also be considered.
  • BS degree and 12+ years of relevant experience will also be considered.

 

Required Experience and Skills:  

  • Subject matter expert with extensive experience in bioassays and ELISA.
  • Deep knowledge and expertise in development, qualification/validation, and troubleshooting of assays for vaccines, mAb’s, ADCs, and proteins.
  • Familiarity with Good Manufacturing Practices (GMP) is strongly desired.
  • Ability to independently analyze and interpret experimental data and to present and discuss results within a multi-disciplinary team environment.
  • Adherence to safety procedures 
  • A team player with excellent oral and written communication skills 
  • Ability to work independently and as a scientific mentor for development and qualification/validation of assays.

 

Preferred Experience and Skills: 

  • Experience with immunological assays such as ELISA, AlphaLISA, multiplexed ligand binding assays (LBA) on Meso Scale Discovery and/or Luminex platforms.
  • Experience with microplate imaging systems and multiplex plate readers preferred. 
  • Familiarity with liquid handlers and other automation platforms for sample preparation and assay process is preferred.
  • Experience in new assay technology evaluation.

 

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Quality Assurance

No Open Roles At This Time

Business Development

No Open Roles At This Time

Human Resources

NJ Bio Inc is a growing chemistry and biotech CRO with laboratories located in Princeton, NJ and Bristol, PA. NJ Bio offers competitive salary, great benefits, and significant growth opportunities within the organization.

NJ Bio is constantly expanding its Human Resources team and is looking for dedicated and talented individuals.

Human Resources Manager (with Life Sciences experience)

Job Responsibilities

  • Responsible for ensuring compliant, efficient, and timely recruitment and staffing efforts for hiring units using the applicant management tool for all staff positions within assigned schools/units. This includes the posting of new and vacant positions, reviewing print/online advertisement, managing applicant pools from screening, and referring candidates to hiring manager, coordinating the selection, employment offers, hiring and onboarding of final candidates, background investigations, and participating in job fairs.
  • Facilitate the employee onboarding process to ensure the employee has a positive experience and has all the training and equipment to operate effectively within the company and role
  • Create and regularly update all job descriptions.
  • Responsible for administering Benefits Program including group health, dental, vision. 401k, Life Insurance. Provide interpretation of benefits and policies to employees.
  • Manage leave of absence and workers compensation programs.
  • Process payroll semi-monthly.
  • Maintains knowledge of legal requirements and government reporting regulations affecting human resources functions and ensures policies, procedures, and reporting are incompliance.
  • Maintain company policies and procedures to ensure equitable practices and legal compliance for the organization. Recommend adjustments to practices as appropriate as laws change.
  • Assist in assembling reports as requested, such as EEO reporting, HR Year-end reports, reporting for regulatory compliance.
  • Assist with the performance evaluation process.
  • Perform other duties as required.


Skills

  • Excellent use of technology including Microsoft Suite, Zoom.
  • Ability to work under multiple deadlines and manage simultaneous projects.
  • Strong problem-solving abilities, time and task management, and organizational skills.
  • Ability to communicate effectively, orally, in writing and to listen actively.


Education and Experience

Bachelor’s degree in human resources or a related field required and 5-7 years of human resources experience or an equivalent combination of both education and experience which meets the required knowledge, skills, and abilities. Experience in a life sciences setting is preferred. Professional in Human Resources (PHR) and or SPHR certification preferred.

 

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Manufacturing - Operations

NJ Bio Inc is a growing chemistry and biotech CRO with laboratories located in Princeton, NJ and Bristol, PA. NJ Bio offers competitive salary, great benefits, and significant growth opportunities within the organization.

NJ Bio is expanding its Global Operations team and is looking for dedicated and talented individuals.

 

Manufacturing Associate I/II

NJ Bio is aggressively expanding at its new Princeton, NJ site. We are looking for a Validation Engineer (title depending on experience) to support cGMP clinical manufacturing operations.

Job Summary

The Manufacturing Associate I/II is responsible for the execution of production activities for early phase small molecule and/or biological programs within a GMP environment.

Key Responsibilities

  • Performs manufacturing operations safely and compliantly in accordance with OSHA and cGMP guidelines. Manufacturing operations include but are not limited to; dispensing and sampling of raw materials, buffer preparation, column packing, UF/DF, chromatography, filtration, product sampling, and filling of bulk product or intermediate.
  • Utilizes standard operating procedures and documents cGMP activities within batch records and logbooks applying good cGMP documentation and data integrity practices.
  • Performs oversight of process operations and monitors equipment and critical process parameters. Escalates any issues or abnormalities to management, senior associates and/or system matter experts. Participates in resulting troubleshooting activities as necessary
  • Completes setup, use and cleaning (as necessary) of cGMP production equipment.
  • Creates and revises SOPs (standard operating procedures) and MBRs (master batch records) as appropriate.
  • Proactively works with senior associates, system matter experts, and management to achieve training competency in production operations.
  • Maintains a clean and orderly production area. Positively engages and collaborates with other team members to ensure daily production tasks are completed in a timely manner.
  • Participates in investigations of safety or quality issues as necessary.
  • Participates and supports a culture of continuous improvement. Effectively collaborates with cross functional partners such as Engineering, Quality Assurance, Quality Control, Supply Chain, and Facilities.

Required Knowledge, Skills, and Abilities

  • Ability to follow detailed instructions and to maintain accurate records and notes.
  • Ability to work effectively in a team environment.
  • Excellent oral and written communication skills
  • Ability to work occasional weekends, holidays or overtime as needed.
  • Familiarity with MS Office applications (Outlook, Word, Excel).
  • Energetic, motivated and dynamic individual.
  • Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.


Job Specifications

Education and Experience Requirements

  • High School Diploma / associate degree with exposure to science & math coursework
  • BA/BS degree in a scientific discipline (life sciences / engineering) – Preferred
  • 0-2 years of cGMP experience

Physical Demands
Ability to lift up to 20kg

Working Conditions
Lab/manufacturing environment

Certificates & Licenses Required
N/A

 

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AD/Director Small Molecule Manufacturing

Job Summary

The following is a job summary of the associate director/director of Small Molecule Manufacturing:

  • Plan and execute daily activities in a multi-product clinical manufacturing facility.
  • Adopt small-scale models constructed during process development and test at large scale via pilot-scale production in manufacturing to determine whether production models are scalable.
  • Coordinate the support of internal and external resources to accomplish production goals with minimal oversight.
  • Oversee manufacturing supervisors, leads chemists and technicians including training, daily assignments and perform document reviews and owning deviations and change controls where applicable.
  • Provide direction and hands-on training for staff.
  • Collaborate with cross-functional teams to resolve technical and logistical challenges e.g. process development, process transfer and supply chain.
  • Foster an environment of safety, quality compliance, strong work ethic and ongoing learning.
  • Lead projects related to continuous improvement, operational readiness, and campaign startup/close out during non-production periods and support activities including non-clinical development runs, recipe programming and testing, and maintenance / qualification / calibration.

 

Note: The position may require off-hour support as needed. Work may include weekends, off hours and holidays.

Key Responsibilities

  • Oversee manufacturing operations, suite and team by coordinating and monitoring activities.
  • Provide necessary program direction (tracking and reporting tools) for planning, organizing, developing, and integrating projects across multiple functional areas.
  • Mentor and manage a growing team of supervisors, chemists, and technicians.
  • Hands-on lead in troubleshooting efforts related to processing and process equipment problems.
  • Writes and/or reviews MBR’s, SOP’s, and other technical documents.
  • Ensures operations are in compliance with all Regulatory, EHS, and cGMP quality systems that assure proper design, monitoring, and control of manufacturing processes and suite.
  • Manages the raw material needs, production schedules, finished product inventories and logistics of shipments.
  • Evaluate and implement new technologies as needed.
  • Reporting of KPIs, operational metrics and project updates to SLT.
  • Act as a change agent to implement necessary manufacturing suite improvements as dictated by business needs.
  • Produce key operations deliverables including URS’s, commissioning, start-up, and operator training.
  • Maintain Quality System and GMP training requirements.
  • Collaborates with the EHS group on environmental, health and safety-related aspects of all operations.
  • Participation in multidisciplinary alignment meetings, safety, and quality risk assessments
  • Effectively partner with diverse internal stakeholders (process chemistry, analytical development, quality assurance, regulatory affairs, manufacturing science and technology, supply chain, quality control, facilities, and manufacturing operators) to build robust processes and supporting resources.

Required Knowledge, Skills, and Abilities

  • Experience in small molecule chemistry and/or manufacturing preferred.
  • >5 years management level experience with ability to develop staff.
  • Excellent interpersonal and communication skills
  • Ability to influence stakeholders and drive decision-making.
  • Proficient in MS Office Software such as Excel, Word, Outlook and PowerPoint.
  • Experience in MasterControl eQMS and eBR is a plus.
  • Experience in Unicorn, Opti-Dry, Rockwell Studio is a plus.
  • Knowledge of chemical engineering principles including reaction kinetics, reactor design, chemical thermodynamics, process modeling, heat, and mass transport a plus.
  • Business acumen including experience with Asana, Smartsheet or Microsoft project or equivalent management tool and proven ability to learn and adapt to new systems
  • Understanding and/or experience in chemical process scale-up and manufacturing of pharmaceuticals
  • Proven record of calm under pressure and a positive attitude.
  • Highly organized.
  • Ability to effectively collaborate.
  • Outstanding communication skills (verbal and written).

 

Job Specifications

Education and Experience Requirements

Minimum of a Bachelor of Science (BS) in Chemical Engineering, Organic Chemistry, Process Chemistry or Physical Chemistry and a minimum of 10 years of experience within Pharmaceutical or CDMO industries. GMP experience a plus.

Physical Demands
N/A

Working Conditions
Office environment with some lab/manufacturing environment

Certificates & Licenses Required
N/A

 

 

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Platform Innovation

BioNMR

Job Summary

Under minimal supervision, plan and execute BioNMR experiments for protein anyalysis, ligand-protein interaction mapping, and protein-protein interactions by multidimensional NMR experiments; support the research and development pipeline with complex NMR analysis and experiment design; bacterial expression of 15N- and 13C/15N- labeled proteins for NMR projects; plan and execute short-term, mid-term and long-term goals; contribute to scientific discussions; stay abreast of current literatures in scientific area, design expression and purification routes for projects; prepare project reports and presentations for research updates; maintain equipment, chemical inventory, and provide lab support; perform duties as required.

Job Responsibilities

  • Execute BioNMR experiments (i.e.) prepare peptide/protein sample, run and monitor NMR experiments, measure and optimize parameters, process and plot data.
  • Execute NMR data analysis (i.e.) solve, visualize, and evaluate structures of proteins; map ligand interaction sites on proteins, and solve structures of protein-ligand complexes.
  • Support the research and development pipeline with complex NMR analysis and experiment design.
  • Plan and execute bacterial expression of produce 15N- and 13C/15N- labeled proteins for NMR projects.
  • Independently execute Start-to-Finish expression (i.e.) (Design of amino acid sequence and synthesis, insertion into cloning vector, sub-clone into expression vector, transform into host, express, purify, remove affinity tag.
  • Preparation and maintain ligand stocks and addition of ligand solutions to proteins of interest.
  • Assist with NMR magnet maintenance and general lab duties including filling magnets with cryogens, monitoring instrument status, and performance, keeping wet lab organized, and ordering reagents/supplies as needed.
  • Contribute to scientific discussions.
  • Stay abreast of current literature in scientific areas.
  • Prepare project reports and research updates.
  • Maintain equipment, chemical inventory, and provide lab support.
  • Perform duties as required.

        Required Knowledge, Skills, and Abilities

        • Extensive knowledge of solution-state NMR spectroscopy analysis and experiment design with hands-on experience with both organic and biological materials.
        • Extensive knowledge of bacterial protein engineering and expression.
        • Experience with yest, mammalian cell, baculovirus-insect cell protein expression would be a plus.
        • Ability to design bacterial expression platform for desired 15N- and 13C/15N- labeled proteins.
        • Ability to plan and execute multiple projects simultaneously.
        • Ability to mentor others.
        • Ability to be an individual contributor.
        • Ability to perform with minimal supervision.
        • Ability to work collaboratively as part of a team.
        • Ability to communicate effectively, orally, in writing, and to listen actively.
        • Ability to apply critical thinking and good problem-solving skills.
        • Ability to demonstrate a willingness to learn.


        Job Specifications

        Education and Experience Requirements

          • Ph.D. in Biochemistry, Chemistry, or Microbiology with 0-2 years industry experience or M.S. in Biochemistry, Chemistry, or Microbiology with 3-5 years industry experience.

        Physical Demands

          • Ability to transport cryogen tanks across site for cryogen maintenance.

        Working Conditions

          • Laboratory and Office environment.

        Certificates & Licenses Required

          • N/A

         

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        Chemist (2 Positions Open)

        Job Summary

        Under minimal supervision, plan and execute chemical syntheses from milligram to hundreds of grams scales; plan and execute short-term, mid-term and long-term goals; contribute to scientific discussions; stay abreast of current literatures in scientific areas; design synthetic routes for projects; prepare project reports for clients; maintain equipment, chemical inventory and provide lab support; Perform duties as required.

        Job Responsibilities

        1. Plan and execute chemical syntheses from milligram to hundreds of grams scales.
        2. Plan and execute short-term, mid-term and long-term goals.
        3. Design synthetic routes for projects.
        4. Contribute to scientific discussions.
        5. Stay abreast of current literatures in scientific areas.
        6. Prepare project reports for clients.
        7. Maintain equipment, chemical inventory and provide lab support.
        8. Perform duties as required.

        Required Knowledge, Skills, and Abilities

        • Extensive knowledge with analytical techniques like mass spectrometry and Nuclear Magnetic Resonance.
        • Ability to design synthetic routes for projects.
        • Ability to plan and execute work on multiple projects simultaneously.
        • Ability to mentor others.
        • Ability to be an individual contributor.
        • Ability to perform with minimal supervision.
        • Ability to work collaboratively as part of a team.
        • Ability to communicate effectively, orally, in writing and to listen actively.
        • Ability to apply critical thinking and good problem-solving skills.
        • Ability to demonstrate a willingness to learn.
        • Ability to maintain confidentiality.


        Job Specifications

        Education and Experience Requirements

          • Ph.D. in Chemistry with 0- 2 years industry experience or M.S. in Chemistry with 3-5 years industry experience.

        Physical Demands

          • N/A

        Working Conditions

          • Laboratory and Office environment

        Certificates & Licenses Required

          • N/A

         

         Confirm Job Qualifier To Apply