What are the responsibilities and job description for the Pharmaceutical Analytical Chemist I position at TriRx Huntsville LLC?
Analytical Chemist Job Description
Job Summary - a concise overview of the job
The successful candidate will be part of a team responsible for ensuring the analytical readiness for incoming projects in a CDMO environment by performing transfer, validation, or verification as appropriate. The position will ensure analytical requirements for new and existing projects are met in a reliable and timely manner while meeting the expectations of TriRx, the customer, and the appropriate regulatory requirements. Strong leadership, scientific writing, and laboratory skills are required.
ROLE AND RESPONSIBILITIES
General Functions:
- Conduct method validation activities in support of API, excipient, finished drug product, and stability testing
- Coordinate Technical Services, Operations, QA, QC, and other relevant departments within TriRx
- Execute protocols for analytical method validation, verification, and transfer to support
- Work as part of a team in conducting method validation/verification/transfer activities
- Write thorough and accurate method validation reports and final test methods in a timely manner
- Report to Principal Scientist —Technical Services/Analytical Development
- Perform other related functions as needed to complete overall company and department objectives
- Additional duties as assigned
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Will have authority to work with customers, other chemists, other departments to conduct analytical activities to support the needs of site and the customers.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
Floor
Operations
- Will work as chemist on the floor of chemistry Laboratories
94%
Non-Conforming Events
- May encounter OOS or non-conformance issues within role
3%
Process Improvement
- May develop methods or improve methods of customer
3%
Compliance
- Ensures compliance with regulatory requirements related to method development and validation
continuous
Safety
- Ensure safety requirements of job
continuous
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
- The following degree in chemistry or related discipline and relevant pharmaceutical experience:
- M.S. with 0-3 years' experience
- B.S. with 0-5 years' experience
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
- Skilled in analytical method development, validation, verification, and transfer
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
- Expertise in chromatography to include HPLC, UPLC, GC, IC, and LCMS as well as spectral (FTIR, UV/VIS, etc)
and wet chemistry techniques on API, excipient, in-process, and liquid pharmaceutical formulations
)=. Commitment to safety, cGMP compliance, and DEA regulations
- Must be able to work in a team environment, communicate, organize, plan, and execute projects
- Strong scientific writing skills required
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
- Must be able to walk and move throughout chemistry laboratory and throughout plant to ensure job is accomplished. Must be able to lift 40 pounds.
