Senior Engineer, ADC Manufacturing

Author and review technology transfer documents, equipment fit gap assessments, and batch records.

Author and review master batch records (MBRs), SOPs, technical protocols and reports

Support Regulatory agency responses for continued regulatory compliance and filing content (IND/IMPDs, BLAs).

Provide technical justification for changes using risk-based methodologies (FMEA, QbD principles).

Education & Experience

Bachelor’s degree in Chemical Engineering, Chemistry, Biology or related field required.

Advanced degree (MS/PhD) preferred.

7+ years of experience in biopharmaceutical MSAT, Process Engineering, or Manufacturing Sciences is required; 2–4 years of experience specifically in ADCs or complex bioconjugation processes is strongly preferred.

Hands on experience with cGMP clinical or commercial manufacturing.

Proven success in working in teams within a matrixed environment.

Demonstrated success in with tech transfers, and process scale up.

Knowledge, Skills, Abilities

Technical understanding of:

Conjugation chemistries (e.g., maleimide thiol, enzymatic, site specific)

Purification technologies (TFF, chromatography)

Experience handling highly potency drug linkers, highly potent active pharmaceutical ingredients (HPAPIs) and knowledge of Occupational Health Category (OHC) classifications.

cGMP and regulatory expectations

Competency with Data analysis tools (e.g., JMP), DOE and multivariate analysis for process performance evaluations.

Familiarity of regulatory issues pertaining to the manufacture of ADCs, large scale biopharmaceutical unit operations and process validations.

Ability to interpret engineering drawings, P&IDs, and equipment manuals.

Ability to perform risk assessments and apply QbD principles to technical decisions.

Ability to lead cross functional technical investigations to closure.

Strong verbal communication, technical writing skills and problem-solving abilities.

Meeting facilitation, technical discussions and alignment across teams and clients.

Ability to operate effectively in a fast-paced, cross-functional team environment.

Work with and mentor junior engineers and manufacturing personnel.

Physical Demands

Lift up to 50 lbs unassisted and perform physical activities such as crouching, kneeling, crawling, climbing stairs and ladders, and walking on level surfaces.

Perform visual inspections of installations and equipment.

On the floor monitoring (if necessary) while using appropriate personal protective equipment (PPE) or Powdered Air Purifying Respirator (PAPR), If necessary.

Ability to work in classified clean-room environments (e.g., ISO8), requiring gowning procedures.

Ability to work around hazardous chemicals, solvents, and high potency compounds while following appropriate control strategies.

Ability to move equipment or materials using carts or similar devices (if applicable).

Work Environment

Work is performed in office and supporting on the floor monitoring (if necessary) while in the controlled manufacturing areas.

May involve exposure to chemical odors, solvents, and high potency materials under controlled conditions.

Work may involve proximity to moving mechanical equipment and standard manufacturing utilities.

Supervisory Responsibilities

This is a senior individual contributor role with technical leadership responsibilities but no direct people management.

Travel

<5% travel required for this role.

Target Bonus

16%

Work Location:

East Syracuse, NY

We are an Equal Employment Opportunity (“EEO”) Employer.

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities! If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!