Job Description

Analytical Chemist

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:

1. M.S. with 0-3 years' experience
2. 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.

Job Tags

Full time, Work experience placement,

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