OB TITLE: Senior Chemist DEPARTMENT: Quality
REPORTS TO: Quality Unit EMPLOYEE STATUS: Exempt
LOCATION: On-site (Dallas, TX) WORK AVAILABLE: Full-Time
JOB SUMMARY:
The Senior Chemist will work as a member of the Quality team leading Analytical Chemistry activities such as Drafting, Reviewing, Executing and Approving Product Formulations. This will include API synthesis in certain situations as well as injectable drug formulations. Addition responsibilities will include Method and Instrument Validation per FDA and ICH requirements.
DUTIES & RESPONSIBILITIES:
- Synthesize and produce APIs as assigned for various projects and needs of the business.
- Ability to develop and optimize synthetic routes, conduct chemical reactions, characterize produced compounds, troubleshoot synthesis issues, scale up processes as necessary, and maintain detailed records.
- Formulate compounds for injectable drug manufacture
- Develop and follow strict aseptic techniques to prepare for manufacture and prevent contamination
- Draft, review and approve documentation for Drug formulation, Instrument Qualification, and Method Validation.
- Complete incoming in-process and finished goods testing and documentation review to ensure all specifications are met.
- Provide oversight and guidance of MCCPMC staff in relation to ensuring cGMP adherence during compounded sterile preparations in relation to chemistry-specific subject-matter.
- Analyze/Review process data to assess trends and propose corrective/preventive actions.
- Assist with quality approval and acceptance, including the release of raw materials, components, and finished products/preparations to ensure quality chemistry work can be conducted.
- Assists in collecting retention samples and monitors drug stability requirements.
- Completes other projects and duties as required and/or necessary.
EDUCATION AND/OR TRAINING:
- Master's Degree in Chemistry or greater.
- Knowledge of and ability to comply to USP Sterile and Non-sterile Compounding requirements and FDA regulatory requirements (i.e. 21 CFR and FDA Guidance documents specific to Drug Manufacturing).
- Expert in lab testing processes and procedures.
WORK EXPERIENCE:
- Minimum of six (6) years of pharmaceutical experience in a pharmaceutical company or quality role.
- Experience leading Analytical Method and Instrument Qualifications per ICH requirements.
- Proven organizational and time management skills.
- Aptitude for decision-making and performing risk assessments.
- Strong computer skills with expert knowledge of Microsoft based programs, related charts and graphs, and analysis skills and techniques to draw necessary subsequent conclusions.
ADDITIONAL PREFERRED QUALIFICATIONS:
- Ability to work independently with little to no supervision.
- Strong communication skills.
- Proactive and hands on.
- Excellent problem solving, analytical and process improvement skills.
- Self-Starter who knows what has to be done and does it
- Completes assigned tasks on time
- Follows instructions
- Excellent verbal and written communication skills.
- Excellent organizational skills and attention to detail.
- Team oriented and mission driven attitude; takes initiative to solve problems that need to be resolved.
- Intelligent. Pays attention to detail and possesses the ability to work in a fast-paced and creative environment.
- Positive, can-do attitude.