Principal Research Scientist I, Biologics Drug Product Development

Description

The Bio DPD group sits within Development Sciences in R&D and works worldwide. It sets the formulation, process and final presentation for biologics such as proteins, conjugates, peptides and neurotoxins, and for genetic medicines such as AAV, LNPs and cell therapy.

This Principal Research Scientist I role is based in North Chicago, IL. You will be a core member of the product development and CMC teams, working closely with discovery, analytical development, bioprocess, combination products, product development science, pilot plants and outside manufacturers. The ideal person has a strong record in biologics drug product work.

Responsibilities

• Serve as drug product team lead and represent Bio DPD on the cross-functional Product Presentation and Device Strategy Team and the CMC Team for one or more programs, from early to late stage.
• Act as the in-house expert on ultra-high concentration co-formulation.
• Direct formulation and process development for biologic drug products, including characterization and robustness studies.
• Guide scale-up of drug product processes and transfer them to internal and external manufacturing sites.
• Keep stakeholders and line management informed about development plans, risks and mitigation steps, promptly.
• Launch or support scientific initiatives that drive innovation, strengthen capabilities and platforms, and improve business processes.
• Manage a team of 2-3 scientists, which may include other DP team leads.

Requirements

• Hold a BS, MS or PhD in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering or a related field, with 14+ years of relevant industry experience for a BS, 12+ for an MS, or 6+ for a PhD.
• Show a track record of resolving difficult scientific problems.
• Have formulation development experience with biologics, parenteral synthetic molecules and/or genetic medicines such as AAV, LNPs and cell therapy.
• Bring experience with sterile unit operations such as freeze-thaw, compounding, mixing, filtration, filling and lyophilization, plus characterization, scale-down models, simulation, scale-up, tech transfer and batch record writing.
• Have led a drug product workstream as functional lead within cross-functional teams.
• Preferred: experience developing and commercializing ultra-high concentration liquid formulations for fixed dose combination products.
• Preferred: hands-on experience writing regulatory filings for biologics and sterile parenteral products.
• Preferred: understanding of relevant cGMP and regulatory guidance for biologics and sterile parenteral products.
• Preferred: experience managing third-party manufacturers of sterile parenteral products.
• Preferred: experience with quality risk management and control strategies for biologics and sterile parenteral products.
• Deep scientific knowledge and substantial hands-on work in ultra-high co-formulation development and characterization.
• Influence without formal authority, pursue technical excellence and encourage continuous improvement.
• Build strong working relationships with peers and cross-functional partners to lift performance.
• Bring ideas from different fields, integrate data quickly, and take risks to reach top performance.
• Set high standards and never accept the status quo.
• Foster a learning environment that welcomes suggestions and experiments.
• Value others' ideas, support innovation, and turn it into practical results.

Conditions

Based in North Chicago, IL.

The base pay range is the company's good-faith estimate for this role at posting, based on the job grade. Actual pay depends on factors such as location and may fall above or below the range, and the range may change.

Bonuses, commissions, incentives and other compensation remain at the company's sole discretion until paid and may change consistent with applicable law. No pay counts as earned until it is vested and determinable.

Equal opportunity employer that welcomes veterans and people with disabilities.

Applications are accepted from the US and Puerto Rico only.

Benefits

• Paid time off, including vacation, holidays and sick leave.
• Medical, dental and vision insurance.
• 401(k) for eligible employees.
• Eligibility for long-term incentive programs.