Supervisor, Quality Control-Biochemistry

About AGC Biologics
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, visitwww.agcbio.com. 

JOB SUMMARY

Manages a team of professionals. Oversees day-to-day quality control processes and teams; monitors compliance with established quality control processes and standards. 

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

• Oversee the day-to-day activities of the Biochemistry Quality Control staff , with an emphasis on cell and gene therapy methodologies.
• Supervise team to follow standards, methods and procedures for analytical test method transfers and / or validation activities ensuring methods meet ICH Q2R2 requirements.
• Review QC team output for compliance with Regulatory Agencies and AGC Biologics  standards to comply with GMP regulations.
• Schedule and supervises daily operations for a project/team comprised of support and/or professional employees.
• Provides technical leadership in the cell / gene therapy space.  
• Prioritizes and assigns project goals; ensures tasks are completed and work area goals are met.
• Conducts mid-year and annual performance reviews for direct reports
• Coordinates with other supervisors and teams to meet the business need and output requirements.
• Train, coach, and mentor team members on task and skill proficiency and performance with manager's guidance.
• Develop staff (i.e. set goals, assign development activities, review performance, etc.).
• Author, review and / or approve QC documentation including but not limited to SOPs, sample plans, product specifications, protocols, and reports.
• Attend customer and internal team meetings as needed to provide project updates.
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LEADERSHIP SKILLS

• Applies understanding of how the team relates to other related areas to improve efficiency of own team.
• Recognizes performance improvements and conveys feedback constructively.
• Works across teams effectively.
• Strong verbal communication, written communication, and interpersonal skills.
• Strong organizational and time management skills to allow for success on multi-project deliverables.

QUALIFICATIONS

Required:

• BS/BA degree with 5+ years of industry experience, or Master's degree with 3+ years of industry experience. Equivalent education and experience may substitute for stated requirements.
• Knowledge or experience in cell and gene therapy methodologies

Preferred:

• Previous experience managing direct reports
• Customer facing experience

COMPENSATION RANGE:

$83,920 - $115,390

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.