Biopharma Manufacturing Associate II

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.

About the role

The Biopharma Manufacturing Associate II will be a key contributor to manufacturing readiness and future operational output of the manufacturing facility. The role will initially support ongoing commissioning and validation activities as the site works towards GMP production readiness, including equipment testing, SOP/batch record generation, and validation protocol execution support. Once commissioning and validation are complete, the role will execute a combination of engineering and GMP clinical batches with supporting staff. This position will help build a diverse and technically strong team for future successful GMP operations.

Responsibilities

• Perform all manufacturing operations under cGMP/ISO requirements
• Demonstrate understanding of upstream process theory (e.g., cell thawing, passages, and harvesting), equipment operation, and aseptic processing
• Assist with the installation, commissioning, and validation of equipment within a single-use facility
• Adhere to manufacturing procedures and documentation, identifying clarifications or updates when required
• Perform legible, clear, and concise data entry into batch records, logbooks, and other ancillary controlled forms used in a cGMP process
• Maintain a high level of quality and compliance with regards to all aspects of manufacturing
• Assist in writing SOPs (standard operating procedures), batch records, and other GMP documentation
• Identify and escalate potential GMP issues as required
• Participate in flexible shifts (Day, Swing, Weekends, Holidays) as directed by facility start-up and future production schedules
• Assist in the evaluation and incorporation of new technologies

Requirements

• BS/BA in Chemical/Biological Engineering or Life Sciences, or Associate’s Degree in science or related field with 1+ years of industry experience
• Experience in maintaining detailed records and assisting in document revisions
• Experience in cell culture with excellent aseptic technique
• Strong skills in biological laboratory math
• Understanding of cGMPs as related to commercial and clinical operations
• Strong communication skills with the ability to work effectively both independently and as part of a team
• Developing problem-solving skills
• Strong computer skills including MS Office (Word, Excel)
• Proven ability to establish and maintain effective working relationships with team members and managers
• Models core values: Be Bold, Care Deeply, Get Stuff Done

Preferred Qualifications

• BioWork Certification or related certifications
• Technical understanding of a biotech manufacturing facility
• Knowledge of upstream process and aseptic technique
• Experience with single-use technologies
• Understanding of FDA regulations
• Experience with continuous improvement platforms and history of identifying changes with positive impact to safety, product quality, and/or operational efficiency
• Ability to clearly define events and associated process conditions during nonconformance or safety escalation efforts
• Ability to multi-task, be flexible, and thrive in a fast-paced environment, including handling uncertainty and changing priorities

Location and Working Environment

• This position is based in Westborough, MA and requires on-site work
• Frequently requires long periods of sitting, standing, use of hands, and regular motion including bending, stooping, and reaching overhead
• Independent mobility to lift up to 25 lbs
• Supports the cleanroom; gowning is expected
• 100% on-site role in a cGMP-regulated manufacturing facility
• Shift work required: 4 x 10s, 12-hour rotating, administrative, or 2nd shift, depending on business needs; shift assigned upon recruitment and subject to change
• Weekend work often scheduled to support staffing and operational needs
• Occasional travel to other Astellas Biopharma Manufacturing facilities (0-5%)

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

Pay

Salary Range: $32.38–$46.25 (final compensation will be determined based on skills, experience, and organizational equity considerations).