Associate Principal Scientist, Bioconjugation

Abzena Inc.; Bristol Township (Bucks County); On-site; USD 120,000 - 180,000; Full time

Job summary

Abzena Inc. in Bristol, PA seeks a Bioconjugation Development Associate/Principal Scientist to drive bioconjugation efforts across discovery to manufacturing. You will lead screening, optimization, purification, and analytical steps, mentor staff, and collaborate with QA, sales, and clients to ensure high-quality, timely results.

The role requires extensive bioconjugation expertise, leadership experience, and hands-on purification and analytical skills, with travel between Abzena sites as needed.

Qualifications

• APhD in chemistry, bioorganic chemistry, chemical biology or similar with >7 years industry experience in bioconjugate development.
• Experience applying bioconjugation or bioorthogonal chemistry techniques to produce conjugates (ADC/PDC/DAC) at various scales.
• Hands-on experience with chromatographic purification systems for biomacromolecules.
• Knowledge of cGMP and GxP principles.
• Prior leadership experience is required.

Responsibilities

• Drive and support technical execution of bioconjugation activities and deliver projects from initial assignment to completion.
• Lead conjugation screening and optimization; manage timelines and resources.
• Mentor and supervise assigned reports.
• Coordinate with QA/QC and management for tox and GLP batch development.
• Assist sales and proposals with SME input and project scoping.

Skills

Bioconjugation

Chromatography

TF/UF filtration

DoE design

Leadership

SME

Education

APhD in chemistry or related field

Tools

AKTA systems

LC-MS

Job description

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

The BioconjugationDevelopmentAssociatePrincipalScientistis responsible forhelping drivebioconjugationefforts indiscovery andprocessdevelopmentto support Abzena Bristol’sscientificand manufacturing operations. This includesconjugationscreening,conjugation reaction optimization, downstream purification developmentand scale-up activities; mentorship, training andpotentialmanagement ofdirect reports;take lead on projects andclient-facing meetings and updates;support sales and proposals process by providing technical and SME supportincluding the design and costing of project activitiesas needed.

Responsibilities

• Driveand supporttechnical execution ofR&D bioconjugation activities andsuccessfully deliver client andinternalcompany projects frominitialassignment to completion.

• Hands-on execution of chromatographic purifications (affinity, hydrophobic interaction(HIC), and ion exchange chromatography(IEX)), membrane filtrations (normal and tangential flow filtrations(TFF)), buffer and solution preparation, conjugation reaction work-up.

• Perform,developandoptimizebioanalytical characterization (HPLC, UPLC, LC-MS,SEC-MALS, colorimetric assays, etc.) of conjugate products.

• Leverageexpertisetoaid in thedesignand management ofproject plans and conjugation strategieswith a focus on improvingproject completion times.

• Serve independently asbioconjugationtechnical lead and subject-matter expert(SME)for internal and external project communications.

• Training, mentorship, and management of assigned reports.

• Monitor and assessdirect report(s)performance through regular tracking of department based KPIs.

• SME and technical supportforsales and proposals teams,including client facing scoping calls, bid defenses and proposal generation.

• Help lead technical transfer ofbioconjugation processes to Abzena’s bioconjugation manufacturing group includingtraining, risk assessment, gap assessments and batch record writing and reviewaccording to ICH and FDA guidelines.

• Authoring andreviewingrelevant documentation including laboratory notebooks, process development reports, protocols, batch records, SOPs, technicalpresentations.

• Provideon-the-floor SME and technical support during complex manufacturing operations as needed.

• CoordinateactivitieswithQA/QCandManagement for development of tox and GLP batches.

• Maintain strong technical understanding of advancements inbioconjugation/bioprocessing through literature searches and review.

• Participate in the hiring process by screening and interviewing candidates.

• Operate to the highest ethical and moral standards.

• Comply withAbzena's policies and procedures.

• Communicate effectively with clients, supervisors,colleaguesand staff.

• Participate effectively as a team player in all aspects of Abzena's business.

• Adhere to quality standards set by regulations and Abzena policies, procedures, andmission.

• Perform other duties as assigned.

• Contribute to assigned laboratory operations including instrument and equipment operations, material shipment preparation, consumablesprocurement.

Qualifications

• APhDin chemistry,bioorganic chemistry, chemical biologyor similarwith>7yearsindustry experience inbiotherapeuticconjugatedevelopment or bioconjugation.

• Demonstrated experienceapplyingandoptimizingstate-of-the-artbioconjugation orbioorthogonalchemistry techniques toproduce conjugates (ADCs, AOCs/ARCs, PDCs,DACs, etc.) at various scales (mg-gram scales)

• Thorough, hands-on experiencewithsmall-scale andpreparative chromatography systems(AKTA Pilot, AKTA Ready, AKTA Explorer, etc.) forpurification of biomacromolecules (antibodies,fusion proteins,carrier proteins, viruses, viral vectors, or otherbiologics).

• Expertiseinnormal flow filtrations and tangential flow filtrations (TFForUF/DF).

• Knowledge of strategies forthe optimizationof bioprocesses and experimental design (DoE).

• Expertisewithquantitative determination of scalable process parameters for normal flow filtrations, tangential flow filtrations, and preparative chromatographic separations.

• Knowledge of cGMP manufacturing operations andGxPprinciples.

• Experience with protein bioanalytical techniques (HPLC, LC-MS,CE-SDS,UV-spectrophotometry, etc.)

• Experience with large scale bioprocess equipment (pallet tanks, pumps,biowelders,biosealers, bio-rockers, single-use assemblies).

• Prior leadership experiencerequired.

Travel between Abzena sites (Bristol PA, San Diego CA, Cambridge UK) as needed.

Physical Requirements

• 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 duringentirelength of shift.

• Use arms,handsand fingers to handle,feelor reach.

• Ability to climb, balance, stoop, kneel, crouch, or crawl.

• Visual abilitiesincludingnear and far sight, color, peripheral vision,depthand ability to focus

FLSA: Exempt

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.