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

ARD & QC Manager, Laboratory Operations

Job Summary

The ARD & QC Manager, Laboratory Operations will lead and manage various laboratory functions to ensure operational efficiency and regulatory compliance. Key responsibilities include the following:

• Equipment and software management.
• Supervise, train, and mentor junior QC scientists and associate scientists.
• Develop and implement corrective and preventive actions.
• Chemical and consumables inventory management.
• Internal safety and cGMP self-inspections.
• Sample management, including outsourced testing.
• EHS management.

The incumbent works cross-functionally with internal departments and external resources on ARD/QC related issues. The ARD & QC Manager, Laboratory Operations, 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.
• Lead and train quality control teams.
• Work with management and vendors to acquire, install, and qualify new equipment.
• Serve as primary contact for negotiation of quotes, service agreements, and contracts.
• Manage and schedule work outsourced to third-party analytical and metrology service providers.
• Develop procedures and SOPs for calibration and OQ of equipment.
• Develop protocols for qualification/validation of software.
• Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
• Manage lab chemicals and consumables including tracking and replenishing inventory.
• Lead internal self-inspections to ensure safety and cGMP compliance.
• Prepare standard operating procedures (SOPs), 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.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills and Abilities

• Proficiency with Microsoft Office.
• Knowledge and experience in cGMP, ICH guidelines, USP, and Ph.Eur.
• Hands-on experience with various analytical instruments.
• 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 fulfill the business need.

Education and Experience Requirements

• BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
• BS with at least 6 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.
• Must have at least 3 years of QC laboratory working experience.

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

$100,000- $130,000 per annum

Confirm Job Qualifier To Apply

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

QC Associate Scientist/Scientist (I/II)

Job Summary

The primary role of the QC Associate Scientist/ Scientist (I/II) is to provide analytical support for GMP manufacturing and process development. The Associate Scientist/ Scientist will work under supervision of senior QC Scientist to 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 Associate Scientist/ 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.
• Routine QC testing of RM, In-process samples, DS, DP and stability samples as per the approved procedures in GMP environment.
• Develop and execute analytical methods for small molecules, proteins, and antibody-drug conjugates under the supervision of a Senior QC Scientist.
• Prepare standard operating procedures (SOPs), analytical test methods, protocols, reports, etc. under supervision as needed.
• 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 under senior QC scientist supervision.
• 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

• Background in analytical sciences.
• Knowledge and experience in cGMP, ICH guidelines, USP, and Ph.Eur.
• Hands-on experience with various analytical techniques including FTIR, UV-VIS, LC, KF, endotoxin etc.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills as well as interpersonal skills.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.

Education and Experience Requirements

• BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
• 0-2 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

$60,000- $80,000 per annum

Confirm Job Qualifier To Apply

No Open Roles At This Time

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

Scientist, Bioconjugation

Job Summary

NJ Bio is seeking a highly skilled Bioconjugation Scientist to independently plan project activities and execute workflows in alignment with project timelines, with a primary focus on Antibody-Drug Conjugates (ADCs) and Antibody-Oligo Conjugates (AOCs). Under minimal supervision, the successful candidate will plan and execute bioconjugation workflows, purify and characterize bioconjugates using LC-MS, HPLC, and other analytical techniques, maintain laboratory documentation and equipment, prepare technical reports, manage project timelines, and comply with all safety protocols, regulatory requirements and Standard Operating Procedures (SOPs). The incumbent will work cross-functionally with internal departments and external partners on bioconjugation-related activities and issues.

Job Responsibilities

• Under minimal supervision, plan, setup, monitor and purify conjugate reaction between small molecules and macromolecules from mg to gram scale.
• Plan and execute short and mid-term bioconjugation goals.
• Working using aseptic techniques.
• Contribute to scientific discussion and help with problem solving.
• Prepare project reports for clients.
• Maintain a detailed lab notebook.
• Maintain equipment and provide lab support.
• Perform safe lab practices.
• Comply with Site safety protocols and Site Standard Operating Procedures (SOPs).
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills and Abilities

• Demonstrate a willingness to learn.
• Excellent verbal and written communication skills and the ability to listen actively.
• 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.

Education and Experience Requirements

Ph.D. in Chemistry, Biochemistry or other related field with 0- 2 years industry experience or M.S. in Chemistry, Biochemistry or other related field with 3-5 years’ experience.

Physical Demands

N/A

Working Conditions

Laboratory and office environment

Certificates & Licenses Required

N/A

Compensation

$80,000-$90,000

Confirm Job Qualifier To Apply

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time