Team Lead BioPharma Manufacturing Operations SFD-TC

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose & Scope

The Supervisor Manufacturing will be a key contributor to manufacturing readiness and future operational output. The role will initially support commissioning and start-up activities as the GMP facility is built. This includes equipment testing, layout planning, SOP and other documentation generation, as well as the recruitment and training of staff. After the startup of manufacturing operations are complete, the role will be responsible for executing a combination of engineering, clinical, and process qualification (PPQ) batches with supporting staff. This role, as part of the Manufacturing leadership team, will be an integral contributor tasked with building a diverse and technically strong team for future successful GMP operations.

Role and Responsibilities

• Ensure seamless transfer of information and responsibilities across shifts and between processing areas

• Hire, train, supervise, and develop subordinate Manufacturing Associates while ensuring all parties are compliant with required GMP training and related documentation

• Support drafting and/or approval of manufacturing documentation, including SOPs and batch records

• Coordinate with other departments to schedule work and other activities that impact manufacturing site milestones and/or process schedules

• Coordinate with Supply Chain and the Warehouse to ensure materials and other consumables are ordered and received in time for both commissioning and production needs

• Support and/or own quality investigations, CAPAs, and other compliance issues, ensuring that process improvement ideas and/or CAPA’s are implemented in a timely manner.

• Support regulatory inspection activities for manufacturing areas, personnel, and procedures

• Attend safety meetings, ensure that staff adheres to all safety procedures as defined, and maintain a safe work environment within manufacturing owned areas

• Review all executed batch records and other documentation generated from the Manufacturing floor and ensure compliance with all approved procedures and cGMP requirements

• Build effective working relationships with cross-functional disciplines, ensuring company goals, process investigations, and improvement initiatives are carried out in an effective and collaborative manner

Required Qualifications

• BS / BA in Chemical/ Biological Engineering or Life Sciences with 4+ years of applicable industry experience or Associate’s degree in science with 6+ years of industry experience or H.S. diploma with 8+ years of industry experience

• 1-2 years of experience leading teams, including peers, in a GMP manufacturing environment

• Technical understanding of a biotech manufacturing facility, with detailed knowledge of fill finish (drug product) operations and working with sterile injectables.

• Proven effective problem-solving skills with an ability react quickly to process challenges

• Strong safety focus with a proven ability to promote safety awareness within manufacturing organization

• Will support and demonstrate quality standards to ensure data of highest quality.

• Outstanding communicator with ability to work independently when required as well as closely within a team that may include external disciplines and key stakeholders.

• Will be expected to perform other duties and/or special projects, as assigned.

• Strong understanding of sterile drug product manufacturing processes and controls, including formulation, sterile filtration, aseptic filling, container closure systems, cleanroom behavior, environmental monitoring, and contamination control.

Preferred Qualifications

• Experience with downstream operations considered an asset.

• Experience with disposable processing equipment

• Experience starting/scaling up a new manufacturing facility

• Excellent aseptic technique

Location and Working Environment

• This position is based in Sanford, NC and will require on-site work.

• This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, regular reaching over head activities, and independent mobility to lift to 25lbs.

• This is an on-site role working in a cGMP regulated manufacturing facility.

• On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities or to third parties to support operations (0-5%)

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.

• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.

• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.

• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’ , working with courage and a sense of urgency . We are outcome focused and consistently take accountability for our personal contribution.

Salary Range

$94,570-$135,100 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations.)

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

• 401(k) match and annual company contribution

• Company paid life insurance

• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

• Long Term Incentive Plan for eligible positions

• Company fleet vehicle for eligible positions

• Referral bonus program

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Category Sanford TC

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans