Senior Scientist I, QC (3rd shift)

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services.

About the role

To support technology transfer and GMP manufacturing activities through analytical method transfer, verification, validation, sample testing and stability study management in compliance with all applicable guidelines. Will also solve moderate complexity analytical and quality control issues for assigned projects and/or initiatives.

3rd shift, working hours: 11:00 pm - 7:30 am. Must be open to working 2nd shift (3pm - 11:30am) as business requires.

Responsibilities

• Participate in method transfer activities, including writing method transfer and method validation protocols, executing experiments and writing reports.
• Mentor junior QC scientists on daily work, provide technical and compliance guidance.
• Conduct method validation, method verification and sample testing.
• Review experimental data, notebooks, method, protocols / reports.
• Actively participate in investigation of laboratory deviations, OOS, OOT, and atypical results. Write investigation reports.
• Prepare and present data summaries (written and oral) as necessary. Present to cross functional teams and effectively communicate critical QC/analytical issues and solutions.
• Ability to work successfully in both a team/matrix environment as well as independently.
• Ensure high quality in QC work and accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
• Participate, support and facilitate site audits as directed and required.
• SME for instrument and training.
• Maintain good laboratory practices and GMP in compliance with safety and environmental requirements.
• Write, revise, develop, and evaluate SOPs.
• Perform other related assignments and duties, as required and assigned.

Requirements

• MS with 8+ years of experience or BS with 10 years of experience in pharmaceutical industry.
• Evidence of experience in successful application of analytical skill sets to resolve scientific problems related to method optimization and/or implementation.
• Experienced troubleshooter of technical problems.
• 3 years of experience (may include Ph.D. experience) with core analytical instrumentation such as HPLC, GC, FTIR, Mass Spectrometry.
• Evidence of ability to effectively contribute to multi-disciplinary scientific teams.
• Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance.
• Evidence of ability to effectively scientifically supervise staff.
• Expert application of core laboratory techniques and instrumentation to impact API, intermediates and starting materials.

Benefits

• Insurance including Medical, Dental & Vision with significant employer contributions.
• Employer-funded Health Reimbursement Account.
• Healthcare & Dependent Care Flexible Spending Accounts.
• 100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance.
• 401k plan with generous employer match.
• Access to an Employee Assistance Program.

Pay

$100,000 - $140,000