*We kindly request that agencies and recruiters do not contact us regarding this position.

 

Director, Analytical Research & Development

Job Summary

The Director, Analytical Research & Development, will lead the analytical development activities of client projects including small molecule linker payload, APIs, intermediates, monoclonal antibodies, proteins, antibody drug conjugates and other therapeutic modalities. Responsible for analytical method development/qualification, product characterization, leading the teams, preparing the presentation for the client meetings and supporting the management team in other activities as needed. He/she will contribute to setting analytical strategy, working with clients on analytical work strategies, and in partnership with internal and external Quality colleagues to play key role in the development. The incumbent works cross-functionally with internal departments and external resources on Analytical Research & Development related issues. He/ she manages direct reports. The Director, Analytical Research & Development ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

 

Job Responsibilities

• Working closely with clients, monitoring client projects and addressing technical challenges in a timely manner.
• Provide strategic, managerial, and technical leadership to the Analytical Development team.
• Design and execute phase-appropriate analytical strategies, including method development, qualification, and validation for ADCs and small molecule drug substances and drug products.
• Lead a team of 4 to 6 senior/principal/group leaders.
• Complex data interpretation, perform statistical analyses, summarize the results, and effectively present data internally and externally.
• Develop and set specifications for raw materials, intermediates, drug substances, excipients, and drug products.
• Establish and manage stability programs for non-GMP and cGMP drug substance and drug product batches.
• Lead the analytical development projects, prepare the teams for client meetings, and review the presentations with the scientists before presenting with clients.
• Lead method development and qualification/validation of physical chemical analytical methods for oligonucleotide, mRNA, mAb, ADCs and linker payload characterization, release, and stability testing
• Manage analytical method transfers from clients for clinical phase GMP testing, and support process technology transfer to cGMP.
• Manage relationships with existing and new clients, including managing timelines and cost for the analytical development in support of manufacturing activities.
• In collaboration with Quality Control, set product release and stability/shelf-life specifications
• Support business development and proposal management teams in writing new proposals and pricing for potential new clients.
• Working on new technology opportunities to support client projects.
• Author, review and approve relevant analytical test methods, qualification/validation/method transfer protocols and reports.
• Author, review and approve relevant Analytical and quality control and other quality related SOPs.
• Manages, coaches, and mentors direct reports
• Perform other tasks and assignments as needed and specified by management.

 

Required Knowledge, Skills, and Abilities

• Knowledge of control strategy for large molecules, drug substance and drug products, phase appropriate method qualifications.
• In-depth mass spectrometry expertise and experience in characterization of ADC’s, mAb’s, proteins and their associated variants and impurities is required.
• In-depth understanding of product characterization of large molecules including ADCs’, monoclonal antibodies and proteins
• In-depth technical understanding of early and late-stage development of ADC products, including CMC Regulatory, Process/Analytical Development, and GMP Manufacturing and QC release and stability testing.
• Leadership and management experience of internal departments.
• Proven leadership experience and understanding influence skills with the desire and ability to work in a fast-paced, collaborative environment. Strong collaboration and team building, communication, and organizational skills required.
• Ability to influence without direct authority.
• Demonstrated leadership ability and experience managing, coaching and mentoring direct reports
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills include the ability to support and prioritize multiple projects.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil business needs.

 

Job Specifications

Education and Experience Requirements

• PhD or MS in chemistry, biochemistry, molecular biology, or chemical engineering with 7+ years of analytical development experience working in the Pharmaceutical or Biotechnology industry.
• 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.
• Hands on experience in analytical method development for ADC’s and small molecule linker payload including HPLC and mass spectrometry-based methods.

Physical Demands

• Stand for extended periods of time with periodic stooping/bending / kneeling.
• Able to lift, push, pull up to 50lbs.
• Work in a lab environment requires special protective clothing over the head, face, hands, feet, and body. This role requires the ability to wear personal protective equipment.

Working Conditions

Laboratory and Office environment

Certificates & Licenses Required

N/A

Compensation

$150,000- $170,000 per annum

 

Confirm Job Qualifier To Apply

 

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

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*We kindly request that agencies and recruiters do not contact us regarding this position.

 

QC Supervisor

Job Summary

The QC Supervisor is a hands-on laboratory position with additional supervisory and management responsibilities. The QC Supervisor will manage a group of QC scientists. The QC Supervisor will develop, qualify, and execute analytical test methods for raw materials, highly potent APIs, antibody-drug conjugates (ADCs), nucleic acids, and other pharmaceutical products in a GMP setting. The QC Supervisor works cross-functionally with internal departments and external resources on QC related issues. This role supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

 

Job Responsibilities

• Manage, coach, mentor, and lead a group of junior scientists.
• Schedule team work assignments based on project deadlines.
• Perform detailed peer review of analytical data to ensure accuracy.
• Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.
• Work with management and vendors to acquire, install, and qualify new equipment.
• Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
• Develop and execute analytical methods for small molecules, proteins, and antibody drug conjugates.
• Analysis of raw materials, in-process samples, finished products, and stability samples by various analytical instruments in a GMP compliant lab.
• Prepare standard operating procedures (SOPs), analytical test methods, protocols, reports, etc. as needed.
• Conduct OOS, risk assessment, and root cause investigations and/or assist senior management with these investigations.
• Write deviations, change controls, and CAPAs, and/or assist senior management with these documents.
• Document work in laboratory notebooks and logbooks according to organizational GDP policies.
• Write, review, and execute analytical protocols & reports for method transfers, qualifications, and validations in GMP setting.
• Manage work outsourced to third-party analytical and metrology service providers.
• Performs other tasks and assignments as needed and specified by management.

 

Required Knowledge, Skills, and Abilities

• Experience in leading people and projects.
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
• Hands-on experience with various analytical techniques, including LC, GC, LC-MS, spectroscopy, electrophoresis, KF, endotoxin, ELISA, etc.
• Knowledge and experience in cGMP, ICH guidelines, USP, and Ph.Eur.
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills as well as interpersonal skills.
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.

 

Job Specifications

Education and Experience Requirements

• BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
• Experience in a GMP manufacturing or CRO setting.
• BS with at least 5 years of relevant experience, MS or higher degree with at least 4 years of relevant experience, or equivalent combination of work experience, education, and training.

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

Compensation

$90,000- $130,000 per annum

 

Confirm Job Qualifier To Apply

 

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

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*We kindly request that agencies and recruiters do not contact us regarding this position.

 

QC Scientist (I, II, III, IV)

Job Summary

The primary role of the QC 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. The incumbent works cross-functionally with internal departments and external resources on QC related issues. The QC Scientist supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

 

Job Responsibilities

• Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.
• Work with management and vendors to acquire, install, and qualify new equipment.
• Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
• Develop and execute analytical methods for small molecules, proteins, and antibody drug conjugates.
• Analysis of raw materials, in-process samples, finished products, and stability samples by various analytical instruments in a GMP compliant lab.
• Prepare standard operating procedures (SOPs), analytical test methods, protocols, reports, etc. as needed.
• Conduct OOS, risk assessment, and root cause investigations and/or assist management with these investigations.
• Write deviations, change controls, and CAPAs, and/or assist management with these documents.
• Document work in laboratory notebooks and logbooks according to organizational GDP policies.
• Write, review, and execute analytical protocols & reports for method transfers, qualifications, and validations in GMP setting.
• Manage work outsourced to third-party analytical and metrology service providers.
• Perform detailed peer review of analytical data to ensure accuracy.
• Perform other tasks and assignments as needed and specified by management.

 

Required Knowledge, Skills, and Abilities

• Strong background in analytical sciences.
• Hands-on experience with various analytical techniques, including LC, GC, LC-MS, spectroscopy, electrophoresis, KF, endotoxin, ELISA, etc.
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills as well as interpersonal skills.
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.

 

Job Specifications

Education and Experience Requirements

• BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
• 0-10 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

Office/ Laboratory position.

Certificates & Licenses Required

N/A

Compensation

$70,000- $110,000 per annum

 

Confirm Job Qualifier To Apply

 

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

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*We kindly request that agencies and recruiters do not contact us regarding this position.

 

QC Scientist (Senior/Principal)

Job Summary

The primary role of the Senior/ Principal QC 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. The incumbent works cross-functionally with internal departments and external resources on QC related issues. The Senior/ Principal QC Scientist supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

 

Job Responsibilities

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

 

Required Knowledge, Skills, and Abilities

• Strong background in analytical sciences.
• Hands-on experience with various analytical techniques, including LC, GC, LC-MS, spectroscopy, electrophoresis, KF, endotoxin, ELISA, etc.
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills as well as interpersonal skills.
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.

 

Job Specifications

Education and Experience Requirements

• BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
• 10+ years of experience in a GMP manufacturing or CRO setting.
• Extensive knowledge of cGMP, FDA, EMA, ICH, USP, and Ph.Eur. guidelines

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

Office/ Laboratory position.

Certificates & Licenses Required

N/A

Compensation

$110,000- $150,000 per annum

 

Confirm Job Qualifier To Apply

 

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

---

*We kindly request that agencies and recruiters do not contact us regarding this position.

 

Scientist, Analytical R&D

Job Summary

Under supervision work on all aspects of analytical methods, including method development, optimization, troubleshooting, qualification, and validation in areas related to some or all the following: LC (SEC, RP, IEX, HIC etc.), mass spectroscopy, capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods. The incumbent works cross-functionally with internal departments and external resources on analytical research related issues. The Scientist, Analytical R&D supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

 

Job Responsibilities

• Under supervision, works on analytical method development, optimization, troubleshooting, qualification, and validation in areas related to some or all the following: LC (SEC, RP, IEX, HIC etc.), mass spectroscopy, capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods.
• Apply routine and specialized analytical techniques to characterize and quantify small molecules such as linker payload and ADCs.
• Maintain reagent supplies, notebooks, summarize results in written reports and communicate observations to ensure that the end user receives quality methods in a timely manner. Comply with Quality Principals related to data generation and reporting.
• Prepare high quality technical presentations and present internally and externally and participate in scientific discussions.
• Stays abreast of current literature in scientific areas
• Authoring analytical test methods, protocols, reports and other documents.
• Maintains lab equipment, orders supply for lab and provides general lab support.
• Perform other tasks and assignments as needed and specified by management.

 

Required Knowledge, Skills, and Abilities

• Must have practical experience with some or all the analytical instruments such as LC (SEC, RP, IEX, HIC etc.), mass spectroscopy (SQD, QQQ & QTOF), capillary electrophoresis and GC for method development.
• Experience with the application of separation, compendial, and spectroscopic techniques for the characterization of linker payloads and ADCs including HPLC (RP, SEC, HIC, IEX), gel and capillary electrophoresis (CE, cIEF).
• Must be able to handle complex data interpretation software and perform statistical analyses.
• Adhere to relevant regulatory guidelines for analytical method qualification/ validation and documentation, ensuring data integrity and compliance with ICH standards.
• Be able to work on multiple projects simultaneously upon being trained in analytical areas under the supervision
• A strong analytical and instrumental skills and a thorough understanding and working knowledge of analytical method development and validation.
• Demonstrates a willingness to learn and work proactively.
• 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.
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil business need.

 

Job Specifications

Education and Experience Requirements

• Ph.D. in Analytical Chemistry, organic Chemistry, Biochemistry or related areas with 0- 2 years industry experience
• M.S. in Analytical Chemistry, Organic Chemistry, Biochemistry, or related areas with 2-4 years industry experience
• More than 6 years of relevant experience with bachelor’s degree.

Physical Demands

N/A

Working Conditions

Office/ Laboratory position.

Certificates & Licenses Required

N/A

Compensation

$70,000- $110,000 per annum

 

Confirm Job Qualifier To Apply

 

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

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*We kindly request that agencies and recruiters do not contact us regarding this position.

 

Senior Scientist, Mass Spectrometry

Job Summary

Independently work on all aspects of analytical methods, including method development, optimization, troubleshooting, qualification, and validation in areas related to some or all the following: LC (SEC, RP, IEX, HIC etc.), mass spectroscopy, capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods. The incumbent works cross-functionally with internal departments and external resources on analytical research related issues. The Sr. Scientist supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

 

Job Responsibilities

• Develop and utilize advanced analytical tools, focusing on mass spectrometry and chromatography-based techniques to characterize mAb’s, proteins, peptides, oligos and ADCs facilitating critical decision-making
• Design and execute LC-MS/MS and LC-QTOF/MS workflows to characterize proteins, peptides, mAb’s and ADCs drug substances, and intermediates.
• Design and execute intact, reduced LC/MS, peptide mapping assays for ADCs characterization to support client projects
• Analyze and interpret complex datasets, providing insights to drive decision-making
• Stay at the forefront of technological advancements in mass spectrometry and other analytical technologies, integrating innovative solutions to enhance current workflows
• Participate in cross-functional project teams, contributing technical expertise to inform project strategies and directions
• Draft technical reports and contribute to scientific publications, patents, and regulatory submissions as necessary
• Mentor junior scientists in experimental design and data analysis to foster a collaborative and productive research environment
• Author analytical test methods, qualification protocols, reports, and other technical documents
• Act as an intellectual resource in the area of expertise by supporting assay troubleshooting, investigations, and improving analytical methods
• Play a key role in improving processes and procedures
• Maintain a culture of safety and ensure safe work practices within the AMD lab
• Adheres to EHS and quality standards set by regulations and company policies, procedures, and mission.
• Communicate effectively with supervisors, colleagues, clients, and vendors.
• Participates in scientific discussions; stays abreast of current literatures in scientific areas
• Performs other tasks and assignments as needed and specified by management

 

Required Knowledge, Skills, and Abilities

• Proven expertise in LC-MS (Waters QQQ, TOF & QTOF), Sciex (QQQ) and software platforms, including Mass Lynx, Empower & Analyst and Protein Metrics Suite, for intact mass deconvolution, peptide mapping analysis, post-translational modifications (PTMs), characterization of charge variants, and disulfide mapping
• Hands-on experience with a wide variety of analytical methods for protein characterization, including but not limited to LC-MS, LC-MS/MS, HIC, SEC, cIEF, IEX, CE-SDS, DLS and DSC.
• Experience in assay troubleshooting and optimization, with a strong understanding of assay development and execution
• Must be able to handle complex data interpretation software and perform statistical analyses
• 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.
• Must have knowledge of cGMPs specially with respect to analytical method transfer etc.
• Strong collaborative skills and ability to work effectively within multidisciplinary teams
• Excellent communication and presentation skills to convey technical information clearly and succinctly
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

 

Job Specifications

Education and Experience Requirements

• Ph.D. or Masters in Analytical Chemistry, Organic chemistry, Biochemistry, or related areas
• 2 – 4 years of experience in analytical method development and problem solving in the pharmaceutical industry required for this position
• Must have at least 1 to 2 years GMP experience

Physical Demands

N/A

Working Conditions

Laboratory environment

Certificates & Licenses Required

N/A

Compensation

$110,000- $150,000 per annum

 

Confirm Job Qualifier To Apply

 

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

---

*We kindly request that agencies and recruiters do not contact us regarding this position.

 

Senior/ Principal Scientist, Analytical R&D

Job Summary

Independently work on all aspects of analytical methods, including method development, optimization, troubleshooting, qualification, and validation in areas related to some or all the following: LC (SEC, RP, IEX, HIC etc.), mass spectroscopy, capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods. The incumbent works cross-functionally with internal departments and external resources on analytical research related issues. He/she manages direct reports. The Senior/ Principal Scientist, Analytical supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

 

Job Responsibilities

• Independently works on analytical method development, method optimization, troubleshooting, qualification, and validation in areas related to LC (SEC, RP, IEX, HIC etc.), mass spectroscopy (QDa, QQQ, TOF, & QTOF), capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods.
• Key aspect is taking a leadership role in proposing and implementing new platform technologies that increase analytical capabilities, improve process efficiencies, and mentor train and develop junior colleagues.
• Independently plans project responsibilities, executes activities against timelines, leads project scientific discussions
• Stays abreast of current literature in scientific areas
• Independently authors and reviews analytical test methods, protocols, and reports and other documents
• Liaises with purchasing to follow up on arrivals and help procurement with selection of materials
• Prepare and present project status and progress updates to client
• Provide input on equipment purchases
• Get regular updates from project group
• Contribute to scientific discussions
• Check and maintain up to date lab notebooks for team on projects.
• Managers, coaches, and mentors direct reports.
• Perform other tasks and assignments as needed and specified by management.

 

Required Knowledge, Skills, and Abilities

• Must have hands-on working experience and deep knowledge in analytical method development, optimization, troubleshooting, qualification, and validation of methods such as LC (SEC, RP, IEX, HIC etc.), mass spectroscopy (QDa, QQQ, TOF & QTOF), capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods.
• Work experience analyzing monoclonal antibodies (mAb’s), oligonucleotides, RNAs, and antibody drug conjugates (ADCs) is a huge plus.
• LC/MS method development for characterization of mAb’s, ADC and Oligo-antibody conjugates is plus.
• Working experience on control strategies for large molecules for DS and DP, phase appropriate national and international regulatory filing strategies.
• Able to develop and execute independently and/or collaboratively all aspects of analytical methods to support bio-conjugation team, process development, product development, in-process monitoring, stability studies for APIs/drug substances/bioconjugates including authoring and reviewing analytical methods, protocols, and reports for clients and stakeholders
• Be a Subject Matter Expert for the team and support assay troubleshooting, investigations, and improving analytical methods and interpret complex data and perform statistical analysis using appropriate software
• Ability to take on a leadership role and be strategic in proposing new technologies to improve process efficiency and increase capabilities
• Plan and execute work on multiple projects simultaneously by collaborating with Chemistry, Bioconjugation, Process Development, Project Management and NJ Bio’s clients on clinical stage APIs/ADCs
• Exhibit strong departmental leadership for best practices of technique, instrumentation, regulatory strategy, project management, processes, information organization, and communication
• Prior experience with training.
• 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
• Communicate effectively with supervisors, colleagues, clients, and vendors.
• Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil business need.

 

Job Specifications

Education and Experience Requirements

• Ph.D. in Analytical Chemistry, Organic chemistry, Biochemistry, or related areas with over 5 – 7 years for Principal Scientist and 2 – 4 years for Senior Scientist
• Proven track record of industry experience.
• Proven track record in analytical method development, project leadership and problem solving in the pharmaceutical or biotech industry
• Must have at least 2 years of GMP experience.

Physical Demands

N/A

Working Conditions

Office/ Laboratory environment

Certificates & Licenses Required

N/A

Compensation

$110,000- $150,000 per annum

 

Confirm Job Qualifier To Apply

 

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.