Jobs · Information Technology · New York

Upstream Process Development Lead

Pfizer · Pearl River, NY · 1 mo ago
Information Technology$106k–$177k/yrFull-time
We need to output HTML fragment with sections: About the role? The posting includes "Role Summary" which could be considered About the role. Use

for section headings. Use
  • for any list of duties/requirements/benefits. Use

    for prose. Do not repeat job title as heading (not given). Do not put Job ID etc. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. Also remove sections like Physical/Mental Requirements? Those are not required headings? The instruction: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text. So we can include sections like About the role (role summary), Responsibilities, Qualifications, Benefits, Pay, Schedule if present. Also maybe "Physical/Mental Requirements" is not a standard heading list; but we could include if content is substantive. However the list of standard headings given: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. They said use

    for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should map content to those headings where appropriate. "Requirements" maybe same as Qualifications? We'll decide. We need to preserve all substantive information. So we need to extract role summary, responsibilities, qualifications, benefits, pay, schedule (flexible schedule). Also maybe "Skills" could be derived from qualifications but we can omit if not explicit. The posting includes "Required:" and "Preferred:" under Qualifications. Also includes "Physical/Mental Requirements" and "Non-standard Work Schedule, Travel Or Environment Requirements". Those could go under Schedule or maybe a separate section but not in list; but we can incorporate schedule info under Schedule heading. Physical/Mental Requirements maybe not needed as a heading; we could embed in Qualifications or Responsibilities? Probably better to include under a section like "Requirements" (physical/mental). But the instruction says we can use headings like Requirements. So we can create a Requirements section for physical/mental and non-standard schedule? However schedule is separate heading. We need to avoid filler like "commensurate with experience". Not present. We must remove EEO boilerplate etc. Also remove "Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com)." That's benefits link; we can keep benefits description but drop the link? The instruction: preserve ALL substantive information; do not invent or summarize away detail. The link is part of benefits info; maybe we can keep as part of benefits paragraph but it's a URL; it's substantive? Might be considered boilerplate? It's a link to benefits page; could be considered navigation? Probably safe to keep as part of benefits description. However they said remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The link is not exactly those; it's a benefits link. Might be okay to keep. We also need to remove "Sunshine Act" etc. That's legal boilerplate; remove. Also remove EEO & Employment Eligibility section. Also remove "Research and Development" at end? That's maybe a category; remove. We need to output only HTML fragment, no /, no markdown fences. Let's craft:

    About the role

    Role Summary This laboratory-based leadership role will lead upstream process development for both mammalian cell culture and microbial fermentation platforms within Vaccines Early Bioprocess Development (EBPD). The incumbent will provide scientific and people leadership for the design, planning, execution, and interpretation of experiments supporting recombinant protein and vaccine antigen production. The role requires strong expertise in upstream process development, including host and cell-line evaluation, media and feed optimization, bioreactor process development, and integration of product yield and quality considerations. The successful candidate is expected to bring deep expertise in at least one platform, mammalian cell culture or microbial fermentation, together with demonstrated knowledge of and ability to lead programs across the other platform. Responsibilities include application of high-throughput and scale-down models, Design of Experiments (DOE), process characterization and modeling, scale-up, technology transfer, and development of processes suitable for good manufacturing practice (GMP) manufacture. Experience with automated and conventional bioreactor systems, such as ambr, stirred-tank bioreactors, and rocking-motion bioreactors, is highly valued. The role requires rigorous documentation, clear communication of data and recommendations, effective cross-functional collaboration, and a proven record of scientific and team leadership.

    But note that "Role Responsibilities" heading follows; we might duplicate content. Better to keep About the role as summary only, not include responsibilities. The role summary already includes some responsibilities; but we can keep it as is. Then separate Responsibilities section.

    Responsibilities

    • Provide scientific and people leadership for the upstream process development workstream spanning mammalian cell culture and microbial fermentation within the Vaccines EBPD Process Development group.
    • Lead the design, prioritization, execution, documentation, and communication of complex studies to improve cell growth, recombinant protein expression, product yield, and quality across mammalian and microbial production systems, using DOE and mechanistic modeling approaches where appropriate.
    • Direct the evaluation and optimization of production hosts or cell lines, inoculum and seed-train strategies, culture media and feeds, and bioreactor operating parameters.
    • Apply platform-appropriate strategies to mammalian cell culture and microbial fermentation while identifying opportunities for common workflows, high-throughput experimentation, automation, digital tools, and continuous improvement.
    • Provide scientific judgment and coaching to direct reports and collaborators.
    • Translate experimental results into clear process development decisions, risk assessments, and recommendations.
    • Lead upstream scale-up and technology-transfer activities through effective cross-functional interfaces.
    • Author or review development reports, process descriptions, and technology-transfer documentation.
    • Represent the Process Development group on project subteams and collaborate with colleagues across Vaccines EBPD and partner organizations to align plans, timelines, deliverables, and issue resolution.
    • Evaluate and implement new upstream technologies that strengthen mammalian cell culture and microbial fermentation capabilities.
    • Maintain current knowledge through scientific literature, external meetings, and internal technical forums.
    • Work a flexible schedule, including occasional work outside core hours or on weekends, when required to support time-sensitive experiments.
    Now Qualifications section. We have Required and Preferred. Could combine into Qualifications. Use
    • for each bullet.

      Qualifications

      Required:

      • PhD in biochemical or chemical engineering, microbiology, cell biology, biotechnology, biochemistry, or a related discipline with at least five years of relevant experience; or an MS/BS with at least 10 years of relevant experience appropriate to the position.
      • Demonstrated expertise in upstream bioprocess development, with deep hands-on experience in at least one of the following areas: Mammalian cell culture or Microbial fermentation using automated or high-throughput bioreactor platforms and conventional systems, such as ambr, stirred-tank bioreactors, rocking-motion bioreactors, perfusion systems, or fixed-bed bioreactors.
      • The candidate must also have sufficient knowledge and experience to lead development activities across both platforms.
      • Hands-on experience developing and optimizing cell culture or fermentation processes in bench-scale bioreactors, including inoculum or seed-train development, media and feed optimization, process-parameter evaluation, sampling, and data interpretation.
      • Experience with recombinant protein or vaccine-antigen expression and with assessing the impact of upstream conditions on product yield and quality.
      • Demonstrated application of DOE, statistical analysis, mechanistic modeling and data-driven decision making in process development.
      • Understanding of scale-up principles and the development of robust processes suitable for GMP manufacturing and technology transfer.
      • Proven ability to lead scientists, manage multiple priorities, solve complex technical problems, and communicate conclusions and recommendations effectively to technical and cross-functional audiences.

      Preferred:

      • Experience across both mammalian cell culture and microbial fermentation, including relevant production hosts such as CHO or other mammalian cells and bacterial or yeast expression systems.
      • Experience with Quality by Design (QbD), process characterization, scale-down models, continuous processing, or advanced process monitoring and control.
      • Working knowledge of current GMP, ICH guidelines, and regulatory expectations for the development of biological manufacturing processes.
      • Familiarity with CMC drug-substance development, technology transfer, process performance qualification, continued process verification, and authoring of investigational new drug application or biologics license application documentation.
      • Working knowledge of harvest and clarification operations, downstream purification, protein chemistry, analytical characterization, and cell-line or strain development.
      • Experience using large or complex datasets, modeling, automation, or digital tools to identify process trends and critical parameters.
      Now Benefits section. The posting includes benefits description. We'll capture that.

      Benefits

      We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com).

      Pay section: salary range and bonus.

      Pay

      The annual base salary for this position ranges from $106,000.00 to $176,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program.

      Schedule section: flexible schedule.

      Schedule

      The work requires a flexible work schedule to properly perform cell culture manipulations. This may involve the necessity of working outside of core hours and on weekends. Relocation support available.

      We also have relocation support mention; we can include in Schedule or maybe a separate line. We'll keep in Schedule paragraph. We should also maybe include "Relocation assistance may be available based on business needs and/or eligibility." That's also in posting after pay. Could add to Schedule or a separate note. But we already have relocation support available in schedule paragraph; we can add more. Let's incorporate: "Relocation support available. Relocation assistance may be available based on business needs and/or eligibility." Now check for any duplicated content: We included flexible schedule in Responsibilities as a bullet; also have Schedule section. That's okay; not duplicate exactly but similar. Might be considered duplication but it's okay to keep both as they are in different contexts. The instruction: remove duplicated lines. The bullet about flexible schedule is a responsibility; the schedule section is about schedule. Not identical lines; okay. Check for any boilerplate left: We removed EEO, Sunshine Act, legal, etc. Also removed "Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States." That's location-specific; maybe we should keep? It's substantive about salary range not applying to Tampa. Could be considered relevant. But it's a limitation; maybe we should keep as part of Pay section. However it's somewhat boilerplate but still specific. I'd keep it as a sentence in Pay. Also "Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not

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