Scientist

Synectics Inc.; North Chicago (IL); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Healthcare Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Job summary

Synectics Inc. in Illinois seeks a Biologics Drug Product Development scientist to lead formulation and process development for biologics, including robustness studies and analytical characterization.

You will drive scale-up and technology transfer to manufacturing sites, applying DoE and regulatory knowledge to ensure quality and compliance. The role requires hands-on experience with biologics formulation, cGMP familiarity, and collaboration with R&D and manufacturing teams.

Qualifications

• Bachelor/Master/PhD in pharmaceutics or related field with 6+–8+ years of industry experience.
• Hands-on experience with biologics formulation development and analytical characterization of proteins.
• Familiarity with DoE, multivariate analyses and data visualization.
• Understanding of cGMP and regulatory guidance, sterile manufacturing experience is a plus.

Responsibilities

• Lead design and execution of biologics drug product formulation and process development, characterization, and robustness studies.
• Support scale-up and technology transfer to internal and external manufacturing sites.
• Communicate study plans, risks and mitigations to stakeholders and management.
• Stay current with advances in biologics formulation and process technologies.

Skills

Biologics formulation

Process development

DoE

Analytical characterization

cGMP familiarity

Scale-up & tech transfer

Regulatory knowledge

Education

PhD in pharmaceutics

MS in pharmaceutical sciences

BS in chemistry

Job description

Responsibilities

• Support needed for drug product formulation and process development on several biologics projects
• Biologics Drug Product Development (Bio DPD), a part of Development Sciences within R&D, is a global organization that is responsible for drug product formulation and process development, and definition of the product presentation for biologics and genetic medicine (proteins, conjugates, peptides etc.).
• Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
• Support scale-up and technology transfer activities to internal and external manufacturing sites.
• Keep abreast of the latest advances in biologics formulation and process technologies.
• Effectively and timely communicates study plans, risks and mitigation plans to stakeholder and line management.
• Understand relevant scientific literature and apply theoretical framework to solving problems within scientific discipline in a timely manner.
• Responsible for compliance with all applicable Corporate and Divisional policies and procedures.
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable.

Qualifications

• Bachelors, Masters, or PhD in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering, or related disciplines with 8+ (Bachelors), 6+ (Masters), or 0+ (PhD) years of relevant industry experience.
• Proven ability to solve critical scientific problems.
• Hands‑on experience with biologics formulation development
• Hands‑on experience with analytical and biophysical characterization of proteins and solid‑state characterization methods.
• Solid understanding of biologics degradation mechanisms and stabilization strategies.
• Hands‑on experience with Design of Experiments (DoE), multivariate statistical analyses and data visualization tools.
• Understanding of relevant cGMP and regulatory guidance.
• Experience with sterile manufacturing unit operations (freez‑thaw, mixing, filtration, filling, and lyophilization) development, characterization, scale‑up and technology transfer.
• Experience with quality risk management and drug product control strategies.
• Proven ability to solve critical scientific problems.
• A proven track record in biologics formulation and process development, and characterization.

Benefits

• Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
• Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
• Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
• 401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.