Supervisor, Manufacturing Projects

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.

SUMMARY:

The Supervisor, Manufacturing Projects supports and leads day-to-day responsibilities of the Manufacturing Project Specialist team, including people management, planning, and ensuring compliance with established processes and standards.

PRINCIPAL RESPONSIBLITIES:

• Maintain a safe work environment.
• Plan priorities for Project Specialists as it relates to procedure and document management.
• Ensure all Project Specialist team timelines are maintained.
• Support the Project Specialist team in completing project deliverables including: GMP document generation/revision, equipment onboarding, CAPA/CR closure, equipment/sample summary, training, and process improvements.
• Ensure compliance with company quality systems, safety procedures, and other company policies.
• Provide training, mentorship, and coaching to staff within the Project Specialist team.
• Represent Manufacturing and Project Specialists at internal and external meetings (e.g. review boards, lot disposition, client facing meetings, and supplier meetings).
• Work closely with Manufacturing and Quality Assurance to drive timely closure of quality records (deviations, CAPAs, and Change controls).
• Provide direction to employees according to established policies and management guidance.
• Prepare and deliver routine reports and communications to site regarding document status.
• Participate in and lead operational improvement projects for Manufacturing operations and the Project Specialist team.

KNOWLEDGE, SKILLS & ABILITIES:

• Strong understanding and ability to apply GMP requirements as they relate to manufacturing operations and quality management systems.
• Demonstrated experience and ability to improve team efficiency via application of team management and understanding how the team relates to other functional areas.
• Detailed knowledge and understanding of the processes, procedures and systems to produce high-quality work within Manufacturing and Project Specialist teams.
• Ability to recognize needed performance improvement and convey feedback in a positive, constructive manner.
• Ability to work across teams effectively with good interpersonal skills.
• Strong problem-solving skills.
• Strong technical writing and communication skills.
• Strong computer literacy required (e.g. QMS such as Trackwise, MS Office Suite, JMP, etc.)
• Ability to don required garments and work in cleanroom environments as needed.

EDUCATION/EXPERIENCE:

• BS in scientific discipline such as Biochemistry, Chemistry, Biology or related discipline required.
• Minimum of 5+ years of GMP biotechnology/pharmaceutical industry experience required.
• Operational expertise of GMP biotechnology/pharmaceutical industry processing equipment (including cell culture, purification, and related CIP equipment) required.
• Previous supervisory experience, or at a minimum, experience leading teams.
• Experience using quality management systems software (e.g. TrackWise) and asset management software (e.g. Blue Mountain) required.
• Operational knowledge of cGMP regulations required.
• Equivalent education and experience may be substituted for stated requirements.

COMPENSATION RANGE:

$94,000 - $129,250

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company's performance and the Team Member's performance.

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.