CMC Scientist / Staff Engineer

About the role

The Contract Scientist will support parenteral drug product development activities with a focus on hands-on in-use compatibility and stability studies, oversight support of drug product manufacturing, and management of technical documentation. The role is intended to provide dedicated technical and operational capacity across mid-stage and late-stage development programs, ensuring studies are executed on schedule, manufacturing activities are appropriately supported, and program documentation is complete and accurate.

Responsibilities

• Design and execute in-use studies for parenteral (injectable/infusion) drug products, including dose preparation, dilution, compatibility, hold-time, filter and infusion-set compatibility, and simulated clinical-administration assessments.
• Test in-use study samples using relevant physicochemical and analytical methods, including micro-flow imaging (MFI) for subvisible particles, pH, osmolality, protein concentration, and size-exclusion chromatography (SEC); generate, review, and trend the resulting data.
• Author study protocols, plans, and reports for in-use and related drug product studies (potentially including formulation and process development studies); interpret analytical results and summarize conclusions to support clinical use instructions and regulatory filings.
• Cooky navigation/legal/EEO/scam-warning boilerplate removed for brevity.

Requirements

• Demonstrated experience in parenteral / sterile drug product development, formulation, or manufacturing support.
• Hands-on experience with in-use, compatibility, and/or stability studies for injectable or infusion products strongly preferred.
• Experience authoring technical documents (protocols, reports, batch records) and working within electronic document management systems (e.g., Veeva, Documentum, or equivalent).
• Familiarity with GMP, GDP, ICH, and data-integrity expectations in a regulated environment.
• Strong technical understanding of parenteral drug product formulation, physicochemical stability, and compatibility principles.
• Solid laboratory skills and familiarity with analytical techniques used to characterize protein/biologic or small-molecule drug products (e.g., appearance, particulates, concentration, aggregation, pH, osmolality).
• Excellent scientific/technical writing skills, with the ability to produce clear, accurate, and well-organized protocols and reports.
• Strong organizational and documentation-management skills, with meticulous attention to detail and version control.
• Effective cross-functional collaboration and communication, able to interface with formulation, manufacturing, analytical, and quality partners.
• Comfortable working on-site in laboratory and adhering to associated gowning and safety requirements.
• Proficiency with standard productivity and data tools (e.g., Microsoft Office; electronic lab notebook and document systems).

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, Biology, or a related scientific discipline with 6+ years of relevant pharmaceutical/biopharmaceutical industry experience; OR
• Master's degree with 4+ years; OR
• Ph.D. with 0-2 years of relevant experience.

Skills

• Working knowledge of drug product manufacturing operations (e.g., compounding, filtration, filling, lyophilization) in a development or GMP environment.
• Strong technical understanding of parenteral drug product formulation, physicochemical stability, and compatibility principles.
• Excellent scientific/technical writing skills, with the ability to produce clear, accurate, and well-organized protocols and reports.
• Strong organizational and documentation-management skills, with meticulous attention to detail and version control.
• Effective cross-functional collaboration and communication, able to interface with formulation, manufacturing, analytical, and quality partners.
• Comfortable working on-site in laboratory and adhering to associated gowning and safety requirements.
• Proficiency with standard productivity and data tools (e.g., Microsoft Office; electronic lab notebook and document systems).

Pay

Commensurate with experience.

Schedule

N/A

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.

Equal Opportunity Employer

Synectics is an equal opportunity employer.