Process Engineer - Drug Product (Hybrid/Remote)

Partner Therapeutics Remote
engineer remote manufacturing technical cmos data operations engineer medical transfer remote patients team
November 23, 2022
Partner Therapeutics
Lynnwood, Washington
Description


PROCESS ENGINEER DRUG PRODUCT (HYBRID/REMOTE)


Partner Therapeutics (PTx) is a commercial biopharmaceutical company committed to improving the lives of patients with cancer and other serious diseases. Our dedicated team brings a rigorous approach to science, establishes deep partnerships with medical and scientific communities, and works tirelessly to expand potential treatment options and address unmet medical needs.


Position Description


The Drug Product Process Engineer ( DPP Engineer ) supports PTx s aseptic drug substance and drug product manufacturing activities at multiple contract manufacturing organizations ( CMOs ). The individual will evaluate and monitor existing manufacturing operations for adherence to validated processes and compliance with industry standards, regulatory requirements, and Current Good Manufacturing Practices (CGMPs). This individual will provide subject matter expertise and technical support for development, technology transfer, and commercial manufacturing activities (including exceptions, investigations, CAPA s, etc.). The position may require travel of up to 5-10% to current and future external CMO facilities in North America and possibly internationally.


Key Responsibilities


  • Provides technical support and guidance for the design, scale-up, optimization, monitoring, and/or operation of the established manufacturing processes validated at the CMOs
  • Tracks and trends key process control elements (PCE), inputs, and yields to ensure current processes are in control and to identify opportunities to improvement
  • Performs periodic statistical analysis of trended PCE data and present data
  • Collaborates with other subject matter experts (SMEs) to ensure data integrity is maintained and data is controlled
  • Ensures timely review/approval of technical documents required to support technology transfer to new CMOs and/or production at current CMOs, including manufacturing documentation, deviations, change controls, CAPAs, risk assessments, etc.
  • Ensures compliance to standards and cGMPs
  • Supports regulatory submissions related to the CMOs


Knowledge, Skills, Abilities


  • Ability to demonstrate thorough understanding and knowledge of drug product manufacturing cGMP requirements, including 21 CFR 210/211, FDA Guidance for Industry, ICH Guidelines, and Industry trends required
  • Working knowledge of pharmaceutical manufacturing unit operations, including, but not limited to dispensing, formulation, sterile filtration, fill-finish, lyophilization, inspection, labeling, and packaging
  • Proven ability to read, understand, and interpret complex regulations, guidance documents, specifications and compendial requirements required
  • Solid English language skills, both oral and written, required. Ability to write clear and concise procedures, and reports; is able to clearly expresses ideas, opinions, questions, and can give effective internal presentations including presenting technical data to a range of audiences required
  • Proficiency with MS Office, with particular emphasis in use of Word, Excel, and SharePoint required. Advanced skills in Microsoft Word and Excel strongly preferred.
  • Proven ability to solve complex problems with high attention to detail, precision, and ability to find errors or inconsistencies
  • Proven ability to work collaboratively across multiple functions, engaging a diverse team that has varying degrees of expertise and technical skills required


Basic Qualifications


  • BA, BS or equivalent in Engineering, Chemistry, or Biological Science required
  • 5+ years of manufacturing/technical operations experience in the biotech/pharmaceutical industry required or 3+ years of similar experience combined with a Master s degree; or a PhD or equivalent work experience required
  • Experience with aseptic fill-finish operations in an FDA-approved manufacturing facility preferred
  • Lyophilization experience strongly preferred


To ensure we are able to consistently provide Leukine to patients around the world and in support of our friends, families, and neighbors, Partner Therapeutics requires all current and future employees to be fully vaccinated against COVID-19. We require evidence of COVID-19 vaccination prior to hire, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.


In addition to medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage, all full-time, regular Partners enjoy a casual, and Hybrid or Remote workplace program for many roles. We offer a terrific compensation/benefits/perks package which includes pre-IPO options, annual cash bonuses, 401k matching, free parking or Seattle-area ORCA pass, tuition assistance, plus rewards for achievement and contribution. To support a healthy work-life balance we also provide a gym subsidy, wellness participation programs, and a generous vacation, sick, and holiday paid time off program in addition to a paid shutdown between the Christmas and New Year s holidays.


Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, age, national origin, veteran status, marital status, sexual orientation, gender identity, disability or any other category prohibited by local, state or federal law. This policy applies to all aspects of employment, including recruitment, placement, promotion, transfer, demotion, compensation, benefits, social and recreational activities, and termination.

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