AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

SUMMARY:

We have an opportunity for a Senior Manager, MSAT Process Validation to join the Manufacturing Science and Technology (MSAT) team at AGC Biologics in Boulder, CO. This team member will lead the effort of process validation activities with a product lifecycle concept for commercial manufacturing process. This is a key leadership position in the MSAT team, reporting to the Senior Director, MSAT, that is responsible for the process validation life cycle approach, control strategy management, and verification for our late phase/commercial portfolio.

PRINCIPAL RESPONSIBILITIES INCLUDE:

Direct and control activities of the department including all people management activities such as establishment of strategic plan, effective delivery of objectives and KPI, project resourcing, mentoring, training, goal setting, and performance evaluation. Also develop and improve the efficiency of the department by setting up the department structure and updating procedures to meet the needs of the clients.
Develop risk-based strategies for the process validation of commercial manufacturing process and ensure application of these requirements throughout the product lifecycle. This includes continuous process verification and control strategy establishment with associated enabling documents (i.e. validation or supporting technical studies).
Design and lead execution of risk assessments and validation studies that are compliant with company’s validation program and aligned with industry’s best practices.
Provide validation support in deviation/investigations, CAPA, and change control.
Review/author relevant technical sections of regulatory dossier or other communications to health authorities, as well as, provide leadership in support of inspections/audits.
As subject matter expert (SME), participate in project evaluations against technical requirements, as well as, leadership/ representation in CMC-related governance meetings. Support Business Develop for potential client presentations and proposal generation.
Improve alignment of process validation activities globally, together with process validation professionals at our other sites.
Interface with the project teams to support product life cycle change management projects, including drive long-term process improvements execution.
Support requests for technical assistance from the rest of the AGC biologics organization globally – ensuring seamless cross-organizational interactions.
The position offer interaction with a large number of internal stakeholders, and is unique in having contact with both our customers and all internal departments involved in process development and manufacturing. You will be introduced to biopharmaceutical companies globally and be an active player in their projects.

KNOWLEDGE, SKILLS AND ABILITIES:

Experience mentoring and developing high performing teams.
Must be self-motivated, organized and proactive.
Ability to work on complex issues where analysis of situations or data requires in depth knowledge of the company objective.
Demonstrated ability to interface/communicate extensively with internal and external clients, including senior management on matters concerning several functional areas, divisions, and/or customers.
Ability to coordinate multi-departmental tasks and deliverables (interaction with Business Development, Process Development, Manufacturing, Engineering, Quality, etc.).
Proven experience successfully managing multiple projects simultaneously.
Prior experience managing technical staff in a GMP environment
Demonstrated ability to build effective working relationships across departments (QA, Process Development, Project Management and Business Development) to support new processes and products.
Demonstrated experience leading troubleshooting efforts.
Strong communication skills necessary to interact with internal and external stakeholders, with an ability to obtain buy-in from all key stakeholders.
Strong presentation skills.
Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks.

EDUCATION/EXPERIENCE:

BS in Engineering or Science, or related / equivalent experience.
Minimum of 10 years of relevant experience and understanding of process validation and biopharmaceutical process development, MSAT and manufacturing.
Minimum 5 years leadership/management experience in Manufacturing, Maintenance, Validation or Process Engineering with a preference toward pharmaceutical or other regulated industries or equivalent experience
Must have experience with and demonstrated understanding of FDA, EMA, and ICH regulations for biologics.
Excellent technical writing skills.
In-depth knowledge of GMP biotech processing requirements.
Equivalent education and experience may substitute for stated requirements

COMPENSATION RANGE:

$148,917 - $178,700 annually

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.

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Senior Manager, MSAT - Process Validation

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