Job Summary:

The Quality Control Lab Manager will support the establishment and operation of our cGMP QC lab including but not limited to: Equipment receipt and installation, lab operations and procedures, good documentation practices and data management, training of QC analyst. Project involvement will start with the cGMP infrastructure and operation needs and will continue through method development, verification and/or validations, on to routine analysis (raw material and release of cGMP products). The ideal candidate is detail-oriented, dependable, and comfortable working in a cGMP-regulated environment. This role contributes directly to PolyPeptide’s commitment to delivering exceptional quality and on-time delivery to our customers.

Key Responsibilities:

1. Creates systems/procedures for recording, monitoring, and maintaining quality results to ensure QC laboratory performed is kept in accordance with cGMP and company procedures.
2. Performs technical expertise for manufacturing deviations, and laboratory investigation. This includes deviation documentation, investigational reports, change controls, CAPAs etc.
3. Writing, reviewing, and approving documentation such as technical reports, standard operating procedures, laboratory protocols, trend analyses, and laboratory investigation.
4. Accurately document all data using Good Documentation Practices (GDP) in compliance with cGMP.
5. Quickly identify and resolve gaps and provide technical support while troubleshooting problems such as equipment, software, data.
6. Facilitate the maintenance of the lab including routine housekeeping, lab inventory, and equipment.
7. Ensure safety is a priority in the QC laboratory by attending safety liaison meetings hosted by the EHS department.
8. Contribute to team building, training, and problem-solving initiatives.
9. Communicate effectively with other relevant groups, including but not limited to Quality Assurance, Manufacturing, and Analytical Development.
10. Contributes to completing project milestones, organizing work to meet project deadlines, and communicating progress on scheduled projects.
11. Participate in routine audits which may include conducting audit tours and completing audit response reports.
12. Oversee MS instruments in QC and coordinate all other equipment receipt and installation

Qualifications:

Education & Experience

• Required Education:
• Bachelor’s degree in relevant scientific discipline.
• Experience:
• 1–2 years of experience managing a team.
• Applied knowledge of GXP, ICH and USP guidelines.
• Ability to comprehend regulatory requirements and technical documentation and objectively make decisions.
• Exemplary verbal, written, communication, multi-tasking, and organizational skills.

Skills & Competencies

• Technical Skills:
• Proficient in Microsoft Office and capable of learning laboratory information systems (LIMS).
• Strong knowledge of analytical methods including HPLC, LC-MS, GC, spectroscopy, and wet chemistry.
• Proven track record of success in leading teams through inspections and audits (FDA, EMA, etc.).
• Experience with peptides, oligonucleotides, or complex APIs is strongly preferred.
• Soft Skills:
• Strong attention to detail, organization, and communication skills.
• Ability to work independently and collaboratively across departments.

Work Environment & Physical Demands:

This role may be based in an office, laboratory, or GMP manufacturing environment, depending on the position. Office-based employees primarily work at a computer in a standard office setting, while lab and manufacturing roles may require work in controlled environments with appropriate gowning and PPE.

Physical demands may include:

• Prolonged sitting or standing, depending on the role.
• Frequent movement between work areas and occasional lifting of up to 25 pounds.
• Performing repetitive tasks, including pipetting, weighing, and data entry.
• Use of hands for data entry, equipment operation, or laboratory tasks.
• Exposure to chemicals, equipment noise, or temperature-controlled environments in lab or production settings.
• Occasional evening, weekend, or overtime hours to meet production or testing deadlines.
• Reasonable accommodations will be made as needed.

Salary: $80K-120K

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.