Supporting BioPharma companies across all CMC aspects, from process development strategies to IND/BLA submission, interim executive leadership roles.
Aktualisiert am 29.09.2026
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 24.09.2026
Verfügbar zu: 100%
davon vor Ort: 100%
MAb development
ADC development
BioPharma executive support
regulatory strategy
IND
BLA writing
GMP manufacturing facility design and qualification
CDMO selection
Organizational build up
CDMO management
Executive development or operational support
Biopharma CMC support
Interim COO
Dutch
Muttersprache
English
fluent
German
good
French
Grundkenntnisse

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

1 year 3 months
2025-07 - now

Consulting, interim, and fractional management services

Founder and owner
Founder and owner
  • Consultancy, interim and fractional (executive) services for full spectrum Biopharma CMC support.
on request
1 year 1 month
2025-07 - 2026-07

Strategic CMC and organizational support

Chief of Staff | MT Member
Chief of Staff | MT Member
  • Strategic CMC and organizational support to the CEO
  • Redesigned and assigned project management qualification large scale vaccines and viral vector GMP manufacturing facility.
  • Business Development to off-load facilities.
Batavia BioSciences, Leiden (Netherlands)
2 years 7 months
2023-01 - 2025-07

innovation-driven biotech pipeline

Chief Operations Officer | Board Member
Chief Operations Officer | Board Member
  • Board-level responsibility for CMC and Technical Operations within an innovation-driven biotech pipeline focused on mAbs and ADCs.
  • Built and scaled CMC capabilities covering Cell Line Development, USP, DSP, Drug Product, Analytical Development, QC, QA, GMP operations and CMC Project Management (100+ FTE).
  • Guided multiple early-stage programs from preclinical development into Phase I clinical studies and to BLA & MAA filings.
  • Design, construction and regulatory approval of in-house GMP facilities including 2x2000L SUB and high potent ADC facilities supporting clinical and commercial supply.
  • Strategic restructuring and organizational realignment following pipeline reprioritization while safeguarding knowledge continuity and execution capability.
Byondis (formerly Synthon Biopharmaceuticals), Nijmegen (Netherlands)
4 years
2009-01 - 2012-12

Biopharmaceutical development

  • Led early and late-stage biopharmaceutical development programs, including biosimilars and innovator biologics.
  • Established development processes, selected CMOs, and delivered clinical trial material for multiple programs.
  • Acted as primary interface for out-licensing biosimilar program.
  • Secured growth of the development organization from approx. 20 to approx. 100 coworkers and construction of new CMC development building
  • Implemented strategies to enable successful early-stage process development and technology transfer
Synthon Biopharmaceuticals, Nijmegen (Netherlands)
6 years
2003-01 - 2008-12

Biopharmaceutical & Biotech Development

  • Led international customer project portfolios and global tech transfer initiatives, including large-scale (25,000 L) cell culture operations.
  • Extensive experience with tech transfer, regulatory documentation, and inspections supporting early clinical to commercial supply.
  • Responsible for technical review of cell culture, fermentation and downstream processes from potential customers, provide budget, writing proposals and contracts.
Diosynth/ Organon/ Schering-Plough, Oss (Netherlands)
10 years
1993-01 - 2002-12

Downstream Processing Development

(Ass) Section Manager
(Ass) Section Manager
  • Responsible for development of purification processes for chemical, biochemical and biotechnological derived products and subsequent transfer to GMP production departments, supply of (pre)clinical material and process validation, regulatory submissions (IMPD/INDs and BLA), pre-approval and regular cGMP inspections by EMA and FDA.
  • Implemented new Biotech commercial manufacturing organization in Dublin, Ireland resulting in EMA approval within 1 year.

Aus- und Weiterbildung

Aus- und Weiterbildung

1986 - 1998
Studie - Chemistry
Utrecht University, The Netherlands
Degree: MSc

1977 - 1983
Studie - Biochemistry
HNWO Dr. Struycken Institute, Etten-Leur, The Netherlands
Degree: BSc

Position

Position

C-level Consultant | Early-stage biotech | CMC Development & Operations

Kompetenzen

Kompetenzen

Top-Skills

MAb development ADC development BioPharma executive support regulatory strategy IND BLA writing GMP manufacturing facility design and qualification CDMO selection Organizational build up CDMO management Executive development or operational support Biopharma CMC support Interim COO

Produkte / Standards / Erfahrungen / Methoden

PROFILE
Senior biotech executive with 35+ years of experience in biologics, mAbs, ADCs and vaccines process development and manufacturing. Supporting innovative and early-stage biotechnology companies in translating scientific discovery into robust, scalable and compliant development and manufacturing platforms. Extensive hands-on experience in building CMC and Technical Operations capabilities from scratch, robust development and regulatory strategy, and preparing early clinical programs for successful progression into late-stage development, commercialization and partnering. Founded AvdL BioPharma Consultancy BV to support the BioPharma industry on CMC and organizational aspects.

CORE BIOTECH EXPERTISE
  • Biologics, mAbs, ADCs, vaccines & viral vector (early to commercial stage) 
  • CMC strategy for biotech pipelines IND/IMPD-BLA/MAA submissions
  • GMP manufacturing & facility design & build-out
  • EMA-FDA regulatory strategy and inspections
  • CDMO selection, governance & tech transfer
  • Scale-up, PPQ & commercial readiness
  • Organizational build-up and restructuring 
  • Pragmatic, flexible but focused
  • Motivating people by being open, trustful and respectful

Branchen

Branchen

BioPharma

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

1 year 3 months
2025-07 - now

Consulting, interim, and fractional management services

Founder and owner
Founder and owner
  • Consultancy, interim and fractional (executive) services for full spectrum Biopharma CMC support.
on request
1 year 1 month
2025-07 - 2026-07

Strategic CMC and organizational support

Chief of Staff | MT Member
Chief of Staff | MT Member
  • Strategic CMC and organizational support to the CEO
  • Redesigned and assigned project management qualification large scale vaccines and viral vector GMP manufacturing facility.
  • Business Development to off-load facilities.
Batavia BioSciences, Leiden (Netherlands)
2 years 7 months
2023-01 - 2025-07

innovation-driven biotech pipeline

Chief Operations Officer | Board Member
Chief Operations Officer | Board Member
  • Board-level responsibility for CMC and Technical Operations within an innovation-driven biotech pipeline focused on mAbs and ADCs.
  • Built and scaled CMC capabilities covering Cell Line Development, USP, DSP, Drug Product, Analytical Development, QC, QA, GMP operations and CMC Project Management (100+ FTE).
  • Guided multiple early-stage programs from preclinical development into Phase I clinical studies and to BLA & MAA filings.
  • Design, construction and regulatory approval of in-house GMP facilities including 2x2000L SUB and high potent ADC facilities supporting clinical and commercial supply.
  • Strategic restructuring and organizational realignment following pipeline reprioritization while safeguarding knowledge continuity and execution capability.
Byondis (formerly Synthon Biopharmaceuticals), Nijmegen (Netherlands)
4 years
2009-01 - 2012-12

Biopharmaceutical development

  • Led early and late-stage biopharmaceutical development programs, including biosimilars and innovator biologics.
  • Established development processes, selected CMOs, and delivered clinical trial material for multiple programs.
  • Acted as primary interface for out-licensing biosimilar program.
  • Secured growth of the development organization from approx. 20 to approx. 100 coworkers and construction of new CMC development building
  • Implemented strategies to enable successful early-stage process development and technology transfer
Synthon Biopharmaceuticals, Nijmegen (Netherlands)
6 years
2003-01 - 2008-12

Biopharmaceutical & Biotech Development

  • Led international customer project portfolios and global tech transfer initiatives, including large-scale (25,000 L) cell culture operations.
  • Extensive experience with tech transfer, regulatory documentation, and inspections supporting early clinical to commercial supply.
  • Responsible for technical review of cell culture, fermentation and downstream processes from potential customers, provide budget, writing proposals and contracts.
Diosynth/ Organon/ Schering-Plough, Oss (Netherlands)
10 years
1993-01 - 2002-12

Downstream Processing Development

(Ass) Section Manager
(Ass) Section Manager
  • Responsible for development of purification processes for chemical, biochemical and biotechnological derived products and subsequent transfer to GMP production departments, supply of (pre)clinical material and process validation, regulatory submissions (IMPD/INDs and BLA), pre-approval and regular cGMP inspections by EMA and FDA.
  • Implemented new Biotech commercial manufacturing organization in Dublin, Ireland resulting in EMA approval within 1 year.

Aus- und Weiterbildung

Aus- und Weiterbildung

1986 - 1998
Studie - Chemistry
Utrecht University, The Netherlands
Degree: MSc

1977 - 1983
Studie - Biochemistry
HNWO Dr. Struycken Institute, Etten-Leur, The Netherlands
Degree: BSc

Position

Position

C-level Consultant | Early-stage biotech | CMC Development & Operations

Kompetenzen

Kompetenzen

Top-Skills

MAb development ADC development BioPharma executive support regulatory strategy IND BLA writing GMP manufacturing facility design and qualification CDMO selection Organizational build up CDMO management Executive development or operational support Biopharma CMC support Interim COO

Produkte / Standards / Erfahrungen / Methoden

PROFILE
Senior biotech executive with 35+ years of experience in biologics, mAbs, ADCs and vaccines process development and manufacturing. Supporting innovative and early-stage biotechnology companies in translating scientific discovery into robust, scalable and compliant development and manufacturing platforms. Extensive hands-on experience in building CMC and Technical Operations capabilities from scratch, robust development and regulatory strategy, and preparing early clinical programs for successful progression into late-stage development, commercialization and partnering. Founded AvdL BioPharma Consultancy BV to support the BioPharma industry on CMC and organizational aspects.

CORE BIOTECH EXPERTISE
  • Biologics, mAbs, ADCs, vaccines & viral vector (early to commercial stage) 
  • CMC strategy for biotech pipelines IND/IMPD-BLA/MAA submissions
  • GMP manufacturing & facility design & build-out
  • EMA-FDA regulatory strategy and inspections
  • CDMO selection, governance & tech transfer
  • Scale-up, PPQ & commercial readiness
  • Organizational build-up and restructuring 
  • Pragmatic, flexible but focused
  • Motivating people by being open, trustful and respectful

Branchen

Branchen

BioPharma

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