What are the responsibilities and job description for the Scientist, Analytical Sciences & Technology position at Unicon Pharma Inc?
Qualifications
- Education & Experience: B.S. in Biology, Chemistry, Biotechnology, or related field with 2–5 years of industry experience, or M.S./Ph.D. with 0–5 years. (Internship/co-op required for new grads; Master’s grads considered.)
- Technical Expertise: Experience in protein/biologics analytics and analytical method lifecycle (development, validation, transfer). Hands-on with HPLC/UPLC, qPCR, ELISA, CE-SDS, iCIEF, SDS-PAGE, UV-Vis, Western blot, mass spectrometry, and cell-based assays preferred.
- Regulatory Knowledge: Familiarity with GMP, CMC, PAT, ICH guidelines, and compendial requirements.
- Additional Skills: Method authoring/validation and QC transfer experience preferred.
- Core Competencies: Strong communication, organization, problem-solving, and ability to manage priorities independently; detail-oriented with a continuous improvement mindset.
Work Environment & Physical Requirements
- Combination of lab and office work; GMP manufacturing exposure.
- PPE required; handling biohazardous materials and chemicals.
- Physical activities include pipetting, lifting (up to 50 lbs), bending, and repetitive hand movements.
- Fast-paced, team-based environment; may require shifts, weekends, or holidays.
Responsibilities
- Support analytical method lifecycle: development, qualification, validation, and transfer.
- Perform non-GMP testing, stability studies, reference standard qualification, and comparability studies.
- Author and review SOPs, methods, protocols, and reports.
- Execute sample testing; analyze, verify, and trend data.
- Troubleshoot analytical issues and support investigations.
- Identify and implement new analytical technologies.
- Contribute to regulatory submissions and support audits/inspections.
- Maintain lab operations (instrument calibration, inventory, housekeeping).
Additional Details
- 8-month contract (extension possible).
- Prefer candidates with protein therapeutics experience and 2–3 years in a scientific role.
- Strong communication skills required.
- Standard schedule: 8 hours/day (M–F), with early arrival before 9 AM huddle