Senior Process Engineer

3 weeks ago

Westborough, Massachusetts, United States Astellas Pharma Full time
Job Description

Technical BioPharma Manufacturing MSAT Engineer MA-TC

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families.

The Senior Process Engineer will be responsible for MSAT activities and deliverables and for providing technical leadership and support to expanding manufacturing process platforms and pipeline in cell / gene therapies. The position will support operations including upstream and downstream drug substance manufacturing and drug product filling.

Key Responsibilities:

  • Deliver a tech transfer and product lifecycle management program that incorporates phase appropriate requirements and expectations, improves tech transfer efficiency, and drives process optimization and cost of goods reduction.
  • Lead tech transfer discussions between sending unit (Research, Process Development, and Pilot Plant) and receiving unit (Manufacturing, QA, QC, Supply Chain, Automation, Process Engineering, and Validation)
  • Author process descriptions, engineering protocols, and technical reports. Create feasibility/gap assessments and facility fit analysis for new products and processes.
  • Drive risk assessments for new processes, process changes, and process comparability
  • Author process comparability protocols for drug substance and drug product
  • Own new product introduction and product phase progression change controls.
  • Manage manufacturing process sample plans (site dependent-Sanford).
  • Support audits and inspections from internal and health authority organizations. Support regulatory interactions and submissions.
  • Collect, organize, analyze, and present process data to enhance process understanding and identify improvements. Author engineering and campaign summary reports. Support process deviation investigations, root cause analysis, and CAPAs
  • Represent MSAT and the site in various CMC meetings with Regulatory and Program Leads

Requirements:

  • MS in Life Sciences with 2 years of relevant experience or BS with 4 years of relevant experience
  • Experience in biologics GMP manufacturing tech transfer
  • Knowledgeable in process and analytical development, phase appropriate technology transfer, process comparability and qualification, CMC regulatory guidelines, process monitoring and analytics, manufacturing operations support, and GMPs, ICH, ISPE, and BPE guidelines.
  • Familiar with QC methods for testing cell/gene therapy Critical Quality Attributes for drug substance and drug product including purity, potency, safety, identity, and physiochemical properties.
  • Must be highly self-motivated, with solid communication skills, and demonstrate the ability to work in a team environment and lead other professionals and peers.
  • Ability to work in a fast-paced team environment with fluctuating priorities and collaborate effectively with others.
  • Excellent organizational and time management skills with ability to set own priorities and strong attention to detail.
  • High degree of flexibility, adaptability, and independence; able to work as needed to meet tight deadlines.
  • Ability to think critically and demonstrated troubleshooting and problem-solving skills.
  • Experience working in cross-functional organization with ability to multitask, prioritize and be an effective and influential decision maker.
  • Demonstrate data integrity standards to ensure data of highest quality.
  • Mentor/train junior staff may manage contractors.
  • Keep current with advances in technologies, evaluate and recommend new technologies that will be useful in expanding and enhancing platform processes; coordinate and champion deployment in manufacturing as appropriate and develop and execute engineering studies.

Preferred Qualifications:

  • Deep knowledge and experience with various human cell culture platforms, especially in human pluripotent stem cell culture and differentiation processes towards products for regenerative medicine
  • Experience in cell/gene therapy GMP manufacturing, scale-up/scale-down, and tech transfer
  • Proficiency in using Microsoft Office software (Excel, PowerPoint, Word), common lab biostatistical analysis software
  • Understanding of industry expectations with respect to phase appropriate requirements while advancing products from clinical to commercial state

Benefits:

  • Medical, Dental and Vision Insurance
  • Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
  • 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
  • Referral bonus program

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