Director, CMC Biologics Job at Proclinical (San Francisco)

Director, CMC Product Development

Location

Denmark , København

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

PhD, MSc, or equivalent in biochemistry, biotechnology, pharmaceutical sciences, or related field
10+ years of experience in CMC development of biologics, preferably antibodies
Proven track record advancing programs from preclinical into clinical development
Strong expertise in bioprocess development, manufacturing, and analytical characterization
Experience working with CDMOs and global regulatory agencies (FDA, EMA)
Deep understanding of GMP requirements and regulatory expectations
Ability to operate both strategically and hands-on in a fast-paced biotech setting

Job Responsibility

Define and lead the CMC strategy for multiple biologics programs
Oversee process development, scale-up, and manufacturing (drug substance and drug product)
Manage and coordinate CDMOs and external partners
Ensure preparation and delivery of high-quality CMC documentation for regulatory submissions (IND/CTA, IMPD, BLA)
Lead technology transfer and manufacturing readiness for clinical supply
Establish and maintain quality standards
Drive analytical development and comparability strategies
Contribute to regulatory interactions and health authority responses
Build and manage internal CMC capabilities as the company grows

What we offer

Be part of a cutting-edge immunotherapy platform with strong differentiation
Work alongside a highly experienced and scientifically driven team
Influence key development decisions and company strategy
Competitive compensation and equity package
Flexible and international working environment

Fulltime

Associate Director, CMC Regulatory Affairs

Associate Director, CMC Regulatory Affairs (RA) who will work closely with our m...

Location

Canada , Vancouver

Salary:

141000.00 - 170000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

Deep understanding of CMC regulatory requirements, eCTD structure, and Module 3 preparation (BLAs/NDAs/NDSs) for biologics and combination products
Ability to navigate regulatory requirements for CMC submissions for biologics and combination products
Thorough understanding of Health Canada, FDA, and EMA regulations
Ability to efficiently oversee independent contractors and vendors
Skilled regulatory writer with effective oral communication skills
Detailed oriented, highly organized, and thrives in fast paced environments while managing multiple priorities
Relevant post-secondary degree(s) in biological, pharmaceutical, chemical, engineering sciences or a related field
About 12 years of relevant work experience

Job Responsibility

Serving as the primary CMC regulatory representative in project meetings and with regulatory agencies
Preparing CMC regulatory submissions including briefing documents, IND submissions, and CTA filings
Overseeing the preparation of responses to regulatory authority queries
Managing critical CMC regulatory timelines, working with team members to navigate the pathways for manufacturing and analytical development, working in close partnership with the CMC and Quality teams
Staying on top of detailed knowledge of the global regulatory environment relevant for biologics, communicating changing regulatory agency requirements, and supporting pertinent regulatory intelligence per needs of programs
Collaborating with external consultants, CDMOs, and CROs to provide regulatory guidance
Evaluating regulatory CMC program risks and establishing mitigation strategies pertinent to product development
Partnering with CMC, Discovery, and Clinical Development teams to innovate strategies to accelerate submission timelines

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship

Fulltime

Senior Director, Quality Assurance

Theradaptive is revolutionizing the field of therapeutic delivery with a pipelin...

Location

United States , Frederick

Salary:

Not provided

Theradaptive

Expiration Date

Until further notice

Requirements

Bachelor's degree (required) in Life Sciences, Biomedical Engineering, Chemistry, Biochemistry, or a related field
Advanced degree (M.S., Ph.D., or M.D.) strongly preferred
15+ years of progressive quality experience in the biopharmaceutical, biotech, or medtech industry, with at least 5 years in a senior leadership role (Director level or above)
Demonstrated experience with combination products, including working knowledge of both drug/biologic and device QMS frameworks
Direct experience managing FDA inspections (PAI, cGMP, QSR) and responding to 483 observations and Warning Letters
Hands-on experience with protein biologics or growth factors (e.g., rhPDGF, BMP, FGF, EGF, VEGF) in a GMP manufacturing or quality context
Experience with sterile or aseptic combination products is highly preferred
Expert-level knowledge of: 21 CFR Parts 210/211 (Drug cGMP), 21 CFR Part 820 / ISO 13485 (Device QMS), 21 CFR Part 4 (Combination Products)
Expert-level knowledge of: ICH Q7, Q8, Q9, Q10, Q11 guidelines
Expert-level knowledge of: ISO 14971 (Risk Management), ISO 10993 (Biocompatibility)

Job Responsibility

Design, implement, and own an integrated QMS that satisfies 21 CFR Parts 210/211 (drug/biologic GMP), 21 CFR Part 820 / ISO 13485:2016 (medical device QMS), and ICH guidelines (Q7, Q8, Q9, Q10)
Ensure the QMS addresses the regulatory designation of the combination product (PMOA-based lead center: CDRH or CDER) and the requirements of the non-lead center
Develop and maintain all quality policies, SOPs, work instructions, and quality plans across the product lifecycle
Drive QMS digital transformation initiatives, including electronic quality management platforms (e.g., Veeva Vault QMS, MasterControl, TrackWise)
Serve as the company's subject-matter expert on 21 CFR Part 3 (combination product designation), 21 CFR Part 4 (regulation of combination products), and applicable guidance documents
Lead cross-functional efforts to align quality requirements for both the protein growth factor drug/biologic constituent and the device constituent part throughout CMC development, scale-up, and commercialization
Oversee the integration of device design controls (21 CFR 820.30) with drug development quality requirements, ensuring alignment in risk management activities per ISO 14971
Collaborate closely with Regulatory Affairs on BLA, PMA, 510(k), or De Novo submission strategies — specifically quality module content (Module 3 / CTD, Design History File, Device Master Record)
Prepare and lead quality-related FDA interactions including pre-submission meetings, Agency responses, and inspection readiness activities
Support compliance with EU MDR 2017/745, IVDR, and country-specific registration requirements for international expansion

Senior Director-Molecule Steward Lead

We manufacture and supply reliable, high-quality medicines and vaccines to meet ...

Location

United States , King of Prussia, Pennsylvania; Wavre, Belgium; Durham, North Carolina; London, United Kingdom; Collegeville, Pennsylvania; Waltham, Massachusetts; Ware, United Kingdom

Salary:

220275.00 - 367125.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

Bachelors degree in life sciences, pharmaceutical sciences, biochemical engineering, or a related field
Experience in biopharmaceutical development, or a related scientific area
Experience supporting molecule program management across preclinical and/or clinical stages
Experience working within cross‑functional, matrixed development teams
Experience working within external regulatory frameworks (e.g., FDA, EMA, MHRA, PMDA) in a pharmaceutical or biologics development environment
Experience supporting technology transfer activities within a product development environment

Job Responsibility

Manage a group of Molecule Stewards (5-10) accountable for end to end technical leadership of various pipeline and in-line programs. Recruit and develop a world class team
Serve on Molecule Steward leadership team to drive and improve portfolio and organizational excellence
Responsible for defining and owning the technical strategy through a product’s lifecycle including product transfers, Product Performance Qualification and Ongoing Continuous Process Verification, leading Product Technical Lifecycle Team (PTLT) and yearly Manufacturing Robustness Review Board meetings
Accountable for developing and delivering the Technical Lifecycle Plan (TLCP) including major geographical expansion, new technologies and second generation programs
Ensures that product history and knowledge from development through the product’s lifecycle is maintained and aligns with knowledge management standards
Providing technical leadership and subject matter expertise where required for multi-site investigations and/or critical deviations, troubleshooting, and major change programmes across supply nodes
Stays current and maintains solid knowledge and understanding of complex scientific subject matter as well as evolving regulatory policies and guidelines and industry best practices
Responsible for co-ordinating the technical review of regulatory submissions and responses to technical questions across MSAT
Representing MSAT, providing an MSAT single point accountable decision maker for GSC strategic team, CMC team, for established and new products
Must develop and manage strong collaborations with technical staff across the Supply Chain sites, MSAT & R&D and maintain and develop technical talent through mentoring across network

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays, vacation, and paid caregiver/parental and medical leave
Annual bonus and eligibility to participate in share based long term incentive program

Fulltime

Director, Platform Technology & Operations

Location

United States , Gaithersburg

Salary:

175000.00 - 250000.00 USD / Year

Piper Companies

Expiration Date

Until further notice

Requirements

10-13+ years in biologics manufacturing
Strong background in process engineering or facilities engineering
B.S. or M.S. in Chemical Engineering, Mechanical Engineering, or related field
7+ years in Process Engineering/Development with facility design exposure
late stage and commercial Pharma experience
Demonstrated experience in process scale up, equipment specification and selection, P&ID development, mass/energy balance calculations, and facility design for biologics manufacturing
Experience with cleanroom design, utility systems (WFI, clean steam, HVAC), material flow optimization, and equipment layout for GMP

Job Responsibility

Set standard for vison of platform, standards of engineering, and define a multi-year roadmap
Create engineering templates and playbooks for platform process descriptions, P&ID standards, utility requirements, and manufacturing technology standards
Set the design principles for facility interfaces (cleanroom and HVAC for example) that enable platform technologies
Set enterprise standards and adoption plans for end‑to‑end processing, including facility design requirements and utility infrastructure
Collaborate with CMC, Clinical, Regulatory, QA, Facilities Engineering, Project Engineering, and site leaders on process risk, equipment selection, facility design, and lifecycle strategies
Lead site technology transfers, facility‑fit assessments, utility definition, equipment installation and qualification protocols, and adoption of digital monitoring/decision tools

What we offer

Cigna Medical
Cigna Dental
Vision
401k w/ ADP
PTO
paid holidays
Sick Leave as required by law

Fulltime

Associate Director, Quality Control Technical Services

Beam Therapeutics is a biotechnology company committed to establishing the leadi...

Location

United States , Cambridge

Salary:

185000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Advanced degree (MS, Ph.D) in Chemistry, Biochemistry, Molecular Biology, or a related scientific discipline, with 8+ years of relevant industry experience in Quality Control, Analytical Development, or CMC within biologics, cell therapy, or gene therapy
Extensive hands-on experience with ex vivo autologous cell therapies, including CD34+ cell-based products, across late-stage development, validation, and/or commercial readiness
Demonstrated technical expertise in cell handling and testing methodologies, including functional and potency assays, flow cytometry, NGS-based assays, and separation sciences. Experience with analytical method automation, qualification, and validation is strongly preferred
Proven understanding of analytical method lifecycle management, including method transfer, qualification, validation, performance monitoring, remediation, and comparability, particularly for late-stage and commercial products
Strong working knowledge of US and EU regulatory expectations (e.g., FDA/CBER, EMA, ICH, USP) applicable to cell and gene therapy CMC, with the ability to apply guidance in a phase-appropriate and inspection-ready manner
Direct experience supporting regulatory submissions (INDs, BLAs, amendments, post-approval changes) for cell and gene therapy products, including specifications, method validation reports, and responses to health authority questions
Demonstrated ability to lead and influence cross-functional program teams, partnering effectively with CMC, Manufacturing, Analytical R&D, Quality Assurance, and Regulatory Affairs in a fast-paced, matrixed environment
Strong communication and leadership skills, with a track record of clearly articulating technical strategies, aligning stakeholders, and driving decisions across functions and with external partners
Documented success in driving complex, program-critical initiatives to completion on time and within budget, including managing dependencies, risks, and priorities across multiple workstreams
Highly developed organizational, analytical, and problem-solving skills, with the ability to interpret complex datasets, assess risk, and translate data into actionable QC and CMC strategies

Job Responsibility

Lead and influence QC CMC strategy in partnership with cross-functional CMC teams for master cell banks (MCBs), plasmids, and mRNA drug substance and critical materials, supporting both ex vivo and in vivo therapy programs across development and commercialization
Define and execute the QC testing, method strategy, and technical execution to enable next-generation autologous cell therapy manufacturing processes, including analytical readiness for process validation, comparability, and technology transfer
Own and coordinate analytical method transfer, qualification, and validation activities across internal and external QC laboratories, ensuring compliant, phase-appropriate, and inspection-ready execution
Establish and maintain analytical control strategies by tracking and trending in-process, release, and stability data, collaborating with statisticians and program teams to define and justify specifications for MCBs, plasmids, mRNA, and autologous cell therapy products
Define and oversee stability strategies and programs for MCBs, plasmids, mRNA, and ex vivo cell therapy products, ensuring alignment with regulatory expectations and lifecycle needs
Lead analytical method lifecycle management for late-stage and commercial ex vivo portfolio, including method performance monitoring, remediation, comparability activities, and continuous improvement
Drive the internalization of validated mRNA analytical methods into Beam's North Carolina Quality Control laboratory, strengthening internal capabilities and supporting long-term commercial supply
Author and review Quality System documentation, including SOPs, Change Controls, and CAPAs, to support method implementation, lifecycle changes, and inspection readiness
Partner with Regulatory Affairs-CMC to author, review, and coordinate CMC sections of regulatory submissions, including specifications, method validation reports, and responses to agency queries
Ensure QC visibility and alignment on regulatory interactions, including tracking agency questions, commitments, post-approval requirements, and method introduction or change strategies

Fulltime

Director, Global Regulatory Lead – Obesity & Related Conditions (Chronic Weight)

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Thousand Oaks

Salary:

195640.25 - 264689.75 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of regulatory experience
Master’s degree and 7 years of regulatory experience
Bachelor’s degree and 9 years of regulatory experience
8–10+ years of global regulatory experience, with demonstrated leadership of regulatory strategy for programs in chronic weight, obesity, metabolic disorders, endocrinology, cardiovascular risk, or related therapeutic areas
Strong scientific literacy in metabolism, energy balance physiology, hormone signaling pathways, adiposity biology, and associated clinical endpoints
Experience developing global submissions and leading interactions with FDA, EMA, and other regulatory bodies
Demonstrated success leading GRTs and influencing governance bodies on complex regulatory and clinical development issues
Proven ability to translate metabolic science into clear regulatory strategy and decision-making frameworks
Strong communication and negotiation skills, with the ability to guide teams through ambiguous or high-stakes situations
Experience in real-world evidence strategy, long-term outcome measures, and chronic disease regulatory considerations is a plus

Job Responsibility

Develop and lead global regulatory strategy for obesity and metabolic disease programs, with specific focus on Chronic Weight, grounded in a strong understanding of metabolic biology, endocrine pathways, adiposity-related physiology, and cardiometabolic risk science
Integrate clinical, nonclinical, CMC, and safety evidence into cohesive regulatory recommendations, accounting for regulatory precedent in obesity and related conditions
Lead the creation of the Global Regulatory Strategic Plan (GRSP), including risk assessment, regulatory scenario planning, and evaluation of novel/expedited pathways
Advises on key clinical development elements relevant to obesity programs—study designs, chronic treatment safety, cardiovascular outcomes evaluation, metabolic biomarker selection, pediatric development, and real-world evidence plans
Lead the Global Regulatory Team (GRT) and represent Global Regulatory Affairs and Strategy (GRAAS) on cross-functional teams
Partner closely with Clinical Development, Safety, CMC, Value & Access, Commercial, and regional regulatory colleagues to ensure seamless strategy execution
Translate complex metabolic science into actionable regulatory strategy for cross-functional partners, facilitating alignment on risk–benefit thinking and long-term labeling strategy
Oversee execution of major global regulatory submissions, including clinical trial applications, initial and supplemental marketing applications, pediatric plans, and labeling updates relevant to obesity programs
Ensure consistency, scientific rigor, and clarity across core regulatory documents—especially TPL, CDS, and briefing materials
Guides the regulatory interpretation of evolving FDA/EMA guidance related to obesity and related conditions (where applicable)

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Global Regulatory Director Lead – Obesity & Related Conditions (Type II Diabetes)

The Director, Global Regulatory Lead (GRL) provides strategic regulatory leaders...

Location

United States

Salary:

189632.45 - 256561.55 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of regulatory experience OR Master's degree and 7 years of regulatory experience OR Bachelor's degree and 9 years of regulatory experience
8–10+ years of global regulatory experience, with demonstrated leadership of regulatory strategy for programs in Type II diabetes, obesity, metabolic disorders, endocrinology, cardiovascular risk, or related therapeutic areas
Strong scientific literacy in metabolism, energy balance physiology, hormone signaling pathways, adiposity biology, and associated clinical endpoints
Experience developing global submissions and leading interactions with FDA, EMA, and other regulatory bodies
Demonstrated success leading GRTs and influencing governance bodies on complex regulatory and clinical development issues
Proven ability to translate metabolic science into clear regulatory strategy and decision-making frameworks
Strong communication and negotiation skills, with the ability to guide teams through ambiguous or high-stakes situations
Experience in real-world evidence strategy, long-term outcome measures, and chronic disease regulatory considerations is a plus

Job Responsibility

Develop and lead global regulatory strategy for obesity and metabolic disease programs with focus on Type II diabetes, grounded in a strong understanding of metabolic biology, endocrine pathways, adiposity-related physiology, and cardiometabolic risk science
Integrate clinical, nonclinical, CMC, and safety evidence into cohesive regulatory recommendations, accounting for regulatory precedent in obesity and related conditions
Lead the creation of the Global Regulatory Strategic Plan (GRSP), including risk assessment, regulatory scenario planning, and evaluation of novel/expedited pathways
Advises on key clinical development elements relevant to obesity programs—study designs, chronic treatment safety, cardiovascular outcomes evaluation, metabolic biomarker selection, pediatric development, and real-world evidence plans
Lead the Global Regulatory Team (GRT) and represent Global Regulatory Affairs and Strategy (GRAAS) on cross-functional teams
Partner closely with Clinical Development, Safety, CMC, Value & Access, Commercial, and regional regulatory colleagues
Translate complex metabolic science into actionable regulatory strategy
Oversee execution of major global regulatory submissions
Ensure consistency, scientific rigor, and clarity across core regulatory documents
Guides the regulatory interpretation of evolving FDA/EMA guidance related to obesity and related conditions

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Comprehensive employee benefits package including Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

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Director, CMC Biologics

Job Description

Job Responsibility

Requirements

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