Full-Time
Senior Manufacturing Specialist
Posted on 10/31/2025
Abzena
201-500 employees
CDMO for complex biologics and ADCs
Compensation Overview
$90k - $120k/yr
San Diego, CA, USA
In Person
 Biology & Biotech (2) |
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- Bachelor’s degree in Engineering, Life Sciences, or related discipline.
- Minimum 3 years of hands-on experience in a cGMP manufacturing environment.
- Demonstrated expertise in root cause analysis methodologies (e.g., 5-Whys, Fishbone, FMEA).
- Proven ability to develop and implement effective CAPAs and sustainable process improvements.
- Strong technical writing skills and excellent verbal communication skills.
- Ability to clearly present technical findings to diverse audiences, including cross-functional teams and regulatory inspectors.
- Strong organizational skills and ability to manage multiple priorities in a fast-paced environment.
- Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
- Frequently lift and or move objects up to 30 pounds.
- Stand/walk during entire length of shift.
- Use arms, hands and fingers to handle, feel or reach.
- Ability to climb, balance, stoop, kneel, crouch, or crawl.
- Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.
- FLSA: Exempt
- Serve as SME for manufacturing operations, equipment, and processes.
- Lead investigations into deviations, process failures, and equipment issues, ensuring accurate root cause identification and timely resolution.
- Author clear, concise, and technically sound investigation reports and CAPA documentation.
- Develop and implement effective CAPAs that address underlying issues and ensure sustainability.
- Drive continuous improvement initiatives to optimize manufacturing processes, increase efficiency, and strengthen compliance.
- Partner with cross-functional teams (Quality, Development, Engineering, Supply Chain) to ensure alignment on solutions and process changes.
- Provide technical expertise and support during regulatory inspections, audits, and internal reviews.
- Analyze production data and KPIs to identify trends, risks, and opportunities for improvement.
- Mentor and support operations staff in applying root cause analysis and problem-solving tools.
- Advanced degree in Engineering, Life Sciences, or related discipline is preferred.
Abzena is a CDMO that provides integrated services for complex biologics and bioconjugates, including antibody-drug conjugates (ADCs). It supports projects from antibody discovery through GMP manufacturing for clinical trials and commercial supply, using its in-house platforms and expertise. It differentiates itself with end-to-end development and manufacturing capabilities, supported by proprietary technologies like ThioBridge and Composite Human Antibody, and global facilities in San Diego, Bristol, and Cambridge. Its goal is to help biologics programs progress efficiently from discovery to market by offering specialized, partnered development and manufacturing services and potential licensing of its technologies.
Company Size
201-500
Company Stage
IPO
Headquarters
Babraham, United Kingdom
Founded
2001
Simplify's Take
What believers are saying
- Geoffrey M. Glass appointed CEO July 22, 2025, drives growth.
- Dr. Moncef Slaoui joins board January 8, 2025, boosts innovation.
- Scientific Advisory Board formed May 15, 2025, guides ADC strategies.
What critics are saying
- Lonza acquires Halo Life Science March 17, 2026, steals ADC share.
- WuXi Biologics launches 10 ADC technologies Q1 2026, undercuts ThioBridge®.
- FDA warning letter halts Bristol PA trials January 15, 2026.
What makes Abzena unique
- ThioBridge® platform creates stable, effective ADCs for clients.
- Composite Human Antibody™ reduces immunogenicity in biologics.
- AbZelectPRO™ launches GS knockout CHO-K1 for afucosylated proteins.
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Benefits
Professional Development Budget
Growth & Insights and Company News
6 month growth
↑ 0%1 year growth
↑ 0%2 year growth
↑ 0%Frost radar report: Antibody-Drug Conjugate contract development & manufacturing organizations. Abzena is recognized as a technology-forward, innovative CDMO in the Frost radar(tm): ADC contract development and manufacturing report, 2025. In this comprehensive analysis of the Antibody-Drug Conjugate (ADC) contract development and manufacturing (CDMO) market, global research analysts Frost & Sullivan, an independent firm, evaluated leading service providers and recognized Abzena as a Leader in both Innovation and Growth. As the author of the report, Unmesh Lal, VP of Healthcare & Life Sciences at Frost & Sullivan, shared, "With deep analytical expertise, flexible licensing models, and a dual US-UK footprint, Abzena combines scientific rigor with commercial agility. Its 'grow-with-the-client' strategy is converting early-stage partnerships into long-term manufacturing relationships, solidifying its position as a premier end-to-end CDMO for complex biologics." * How Abzena's proprietary ThioBridge(R) site-specific conjugation platform improves the design & delivery of ADCs. * How a fully integrated end-to-end development and manufacturing model eliminates tech-transfer risks and reduces timelines & costs. * How assay development for complex ADC & AOC characterization provides the data needed to de-risk clinical programs & build confidence with regulators and investors * How a dual US and UK integrated footprint provides a secure supply chain and deep FDA and EMA regulatory expertise.
Abzena enhances abzelectpro(tm) cell line offering with new GS knockout platforms san diego, CA - september 15, 2025 - abzena, the leading end-to-end integrated CDMO for complex biologics and bioconjugates, announced the expansion of its abzelectpro(tm) cell line development (CLD) platform with the launch of two next-generation glutamine synthetase ("GS") knockout CHO-K1 expression systems, including a double knockout ADCC+ platform for afucosylated proteins.
San Diego, CA - July 22, 2025 - Abzena, the leading end-to-end integrated CDMO + CRO for complex biologics and bioconjugates, today announced that Geoffrey M. Glass has been appointed Chief Executive Officer (CEO), effective immediately.
SAN DIEGO, May 15, 2025 /PRNewswire/ -- Abzena, the leading end-to-end integrated CDMO + CRO for complex biologics and bioconjugates, has announced today the formation of its Scientific Advisory Board (SAB) comprised of biopharma industry experts with diversified expertise in Discovery Research & Development (R&D) and Chemistry, Manufacturing, and Controls (CMC). The new advisory board will work closely with Abzena's scientific and commercial leadership to provide strategic guidance and expert insights that support Abzena's continued commitment to growth and innovation.Matt Stober, CEO of Abzena, said, "The establishment of the Scientific Advisory Board was a strategic decision to help guide the future of Abzena. We have seen considerable momentum over the past few years in supporting complex and innovative modalities, such as Antibody-drug conjugates (ADCs), Antibody-oligonucleotide conjugates (AOCs), and bispecifics. We aim to continue building upon this by offering the most state-of-the-art technologies and capabilities to support our customers' programs. These experts will be instrumental in assisting us with this mission by evaluating our strategies and providing recommendations that will further enhance our ability to move medicines forward to patients faster."Joe Principe, CCO of Abzena, said, "We are honored to welcome these distinguished individuals to our Scientific Advisory Board. These founding members are recognized leaders in our industry, bringing a wealth of expertise that will help guide us as we continue through this significant phase of our growth
Archetype is partnering with contract research organizations (CROs) Abzena and Alloy Therapeutics, to design and develop Antibody-drug conjugates (ADCs) using some of the clinical stage and approved targeted therapy small molecules featured in the presentation.