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New · posted Oct 31

Crescent Biopharma · Biotechnology

Senior Director, Quality Control

  • Waltham, MA
  • On-site
  • Full-time
  • Director
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Pay$260K–$285K
EmploymentFull-time
LocationWaltham, MA
LevelDirector
FunctionQuality Control
DeadlineOpen until filled

The role

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies as single agents and as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.

We are seeking an experienced Senior Director, Quality Control to join as a key leader within Crescent's Quality organization, responsible for providing strategic and hands-on Quality Control leadership across company’s biologics and ADC programs, and future pipeline growth. Partnering closely with Analytical Sciences, GMP Quality Assurance, CMC/Technical Operations, Supply Chain, and Regulatory Affairs, you will provide phase-appropriate QC oversight from early development through late-stage development and commercialization within a global outsourced testing and manufacturing network. You will ensure reliable release and stability testing while building the QC infrastructure, laboratory network, and operating controls needed to advance programs into Phase 3, PPQ, BLA/MAA submission, and commercial readiness.

Crescent's operating model requires clear, collaborative accountability between Analytical Sciences and QC. Analytical Sciences leads analytical development and performs the primary technical work through method development, characterization, qualification, validation strategy, and PPQ readiness. QC provides oversight and operational input during early development, assumes increasing responsibility for method transfer, validation execution oversight, laboratory readiness, and GMP testing as programs mature, and takes primary ownership of routine QC operations and analytical method lifecycle management following transition to late-stage and commercial operations.

Success in this role requires a collaborative, hands-on leader who understands both analytical development and commercial QC operations, can establish effective governance across internal and external partners, and thrives in a fast-paced biotechnology environment while balancing scientific rigor, compliance, speed, and pragmatism.

What you need

  • Bachelor's degree in life sciences, analytical sciences, biochemistry, pharmaceutical sciences, or a related discipline; advanced degree preferred.
  • A minimum 10-12 years of progressive experience in biologics QC, analytical development, or related CMC functions, including leadership of GMP QC operations in an outsourced environment.
  • Experience with biologics analytical methods, including cell-based bioassays/potency assays; ADC and other complex biologic modality experience is preferred.
  • Experience supporting biologics from clinical development through Phase 3, PPQ, BLA/MAA, and commercial readiness; bispecific antibody, ADC, or other complex modality experience is a plus.
  • Proven experience transitioning methods from development into routine GMP QC use, including qualification, validation, transfer, implementation, performance monitoring, and lifecycle management.
  • Strong experience with release and stability testing, specifications, reference standards and critical reagents, OOS/OOT/OOE investigations, analytical trending, deviations, CAPAs, and change control.
  • Demonstrated success overseeing CDMO QC functions and contract laboratories, including qualification, governance, investigations, capacity, performance, and issue resolution.
  • Strong knowledge of global GMP regulations, FDA/EMA/ICH guidance, compendial expectations, data integrity, Part 11 / Annex 11, and phase-appropriate application across development and commercial operations.
  • Experience supporting regulatory submissions, health authority questions, pre-approval inspections, and commercial inspection readiness.
  • Ability to establish clear roles and effective collaboration among Analytical Sciences, QC, GMP QA, CMC/Technical Operations, Regulatory Affairs, Supply Chain, and external partners.
  • Strategic thinker with a hands-on approach, solutions-oriented leader who communicates clearly, applies pragmatic science- and risk-based judgment, works effectively in a fast-paced small-company environment, and can travel to external sites as needed.
  • Commitment to living Crescent’s core values and operating norms.

    • Skills named in this posting

    What you'll do

  • Define and implement Crescent's phase-appropriate QC strategy and operating model across early development, Phase 3, PPQ, regulatory submission, and commercialization, with clear decision rights and handoffs among Analytical Sciences, QC, and GMP QA.
  • Oversee QC activities for drug substance, drug product, intermediates, finished goods, in-process, release, characterization, and stability testing across the portfolio.
  • Provide QC oversight and operational requirements during early development while Analytical Sciences leads method development, characterization, qualification, validation strategy, and method maturation through PPQ readiness.
  • Partner with Analytical Sciences on integrated Phase 3 and PPQ readiness, including method validation and transfer, laboratory qualification, specifications, reference standards and critical reagents, stability, sample management, and testing timelines.
  • Lead QC execution oversight for method transfer, validation, and laboratory readiness; following transition to GMP QC operations, own routine method lifecycle management, performance monitoring, changes, revalidation, transfers, and remediation.
  • Lead outsourced GMP QC operations, including sample management and testing coordination, and ensure timely, compliant release and stability testing for clinical supply, PPQ, batch disposition, regulatory commitments, and future commercial supply.
  • Partner with Analytical Sciences, CMC, Regulatory Affairs, and QA on specifications and stability strategy; lead operational implementation, stability execution, data review, trending, and escalation within the QC network.
  • Establish and oversee reference standard and critical reagent programs, including qualification, bridging, inventory, monitoring, replacement, and lifecycle planning.
  • Provide technical leadership for OOS, OOT, OOE, atypical results, invalid assays, laboratory deviations, CAPAs, and change controls, ensuring scientifically sound, timely investigations and risk-based escalation.
  • Lead selection, onboarding, qualification, governance, and performance management of CDMO QC functions and contract laboratories, including agreements, capacity, metrics, issue management, data integrity, and inspection readiness.
  • Provide QC input to CMC and regulatory strategies and support IND/IMPD, BLA/MAA, health authority, and inspection activities; ensure commitments are implemented within the laboratory network.
  • Lead alliance management with business partners on QC matters, including governance, roles and responsibilities, shared testing and release requirements, issue escalation, decision-making, and alignment on development, regulatory, and future commercial priorities.
  • Establish scalable QC procedures, systems, metrics, budgeting, forecasting, and resource plans; support compliant use of LIMS, stability, analytical data, and trending tools, and build internal QC capability as Crescent advances toward commercialization.
  • Mentor staff and consultants and foster a culture of scientific rigor, collaboration, accountability, inclusion, and continuous improvement while staying current with evolving GMP, ICH, compendial, and industry expectations.

    • Pay

    $260,000 – $285,000 a year

    Employer provided
    How this compares

    The salary range for this position is $260,000 to $285,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

  • Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment
  • Competitive compensation, including base salary, performance bonus, and equity
  • 100% employer-paid benefits package
  • Flexible PTO
  • Two, one-week company-wide shutdowns each year
  • A commitment to your professional development, with access to resources, mentorship, and growth opportunities

    • Where you'll work

    Waltham, MAOn-siteOpen in Maps (opens in a new tab)

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    Equal opportunity, accessibility and legal noticesCrescent Biopharma's statements, word for word

    Additional Description for Pay Transparency

    The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation – Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits

    Please note:

    Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.

    Please note, Crescent does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Crescent and the agency. Crescent will not pay any fees related to unsolicited resumes.

    Job intelligence

    The context around this role

    Live data · October 31, 2026

    Salary intelligence

    How the pay compares

    This role's midpoint is 37% above the US median for Quality Control roles at this level.

    This roleEmployer provided

    $260,000 to $285,000 a year

    Director roles in Massachusetts7 roles publishing pay

    Middle half $193,250 to $258,750, median $215,500

    Director roles in the US25 roles publishing pay

    Middle half $188,000 to $245,000, median $198,500
    Annual base pay
    Annual base payLowMedianHigh
    This role$260,000—$285,000
    Massachusetts$193,250$215,500$258,750
    All US$188,000$198,500$245,000

    This role: Crescent Biopharma's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.

    Career trajectory

    Where this role sits in Quality Control

    The general path across 345 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Crescent Biopharma's own promotion track.

    1. Earlier

      Associate & Specialist

      Often: Quality Inspector · Quality Control Inspector

      $60K median194 open

    2. Earlier

      Senior & Principal

      Often: Quality Control Inspector · Scientist, Quality Control

      $95K median88 open

    3. One step back

      Manager

      Often: Supervisor, Quality Control · Manager, Quality Control

      $112K median38 open

    4. This role

      Director

      Often: Associate Director, Quality Control · Senior Director, Quality Control

      $199K median25 open

    Skills DNA

    What this role leans on

    How many of the posting's 6 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

    GMP and compliance: 5 linesLab testing and methods: 5 linesDocumentation and SOPs: 1 lineInvestigations and CAPA: 2 linesValidation and qualification: 3 linesRegulatory submissions: 3 linesQuality systems and risk: 2 linesData and digital systems: 2 linesClinical trial conduct: 1 lineCollaboration and leadership: 6 linesGMPLab testingDocumentationInvestigationsValidationSubmissionsQuality systemsData systemsClinical trialsTeamwork
    • Collaboration and leadership6
    • GMP and compliance5
    • Lab testing and methods5
    • Validation and qualification3
    • Regulatory submissions3
    • Investigations and CAPA2
    • Quality systems and risk2
    • Data and digital systems2
    • Documentation and SOPs1
    • Clinical trial conduct1

    Regulatory intelligence

    The rules behind this role

    Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

    From Regulatory News

    Manufacturing and quality coverage for this profession

    Company hiring pulse

    Crescent Biopharma on Regulatory Jobs

    3
    Open roles
    3
    Distinct roles
    1
    Locations

    By discipline

    • Regulatory1 33%
    • Quality1 33%
    • Clinical1 33%

    By level

    • Director2 67%
    • VP & Executive1 33%
    See all 3 Crescent Biopharma roles

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    Similar Quality Control roles elsewhere

    Senior Director, Quality Control at Crescent Biopharma

    Open until filled. $260K–$285K a year, employer provided.

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