Manages and executes analytical method development and validations.
- Develops robust, cost-effective analytical methods consistent with product and regulatory requirements; prepares method development reports and related method documentation.
- Drafts and executes method transfer, qualification, verification and validation protocols; authors associated reports.
- Manages and interacts with external test labs to effectively execute method development, testing, stability evaluations, validations, etc. as necessary to support new business opportunities. Works with Business Manager, Project Manager and Functional Leadership to coordinate activities in the most effective manner. Takes lead in determining which methods to outsource, when to bring them in-house, what labs to utilize, etc.
- Manages, in collaboration with QC, the effective transition of methods into routine quality testing.
- Independently performs materials analysis of substantial variety & complexity as needed using the company test methods, compendia methods, specifications.
- Ensures all analytical operations comply with cGMPs & the company procedures and all laboratory experiments are properly documented in notebook and are in accord with regulatory requirements.
- Conducts and/or consults on investigation of out-of-specification (OOS) or out-of-trend (OOT) results where needed.
- Leads and consults (where necessary) on new equipment specification, acquisition and qualification.
- Specializes and acts as lead expert in consulting with others (internally and externally) to resolve analytical related issues and planning future capabilities and resource requirements.
- Mentors and develops others in method development and validation.
- Abide by the company’s Laboratory Chemical Hygiene Plan and other safety policies. Maintains a safe and clean work environment, notifying the supervisor of unsafe practices, conditions, or acts; takes on increasing responsibility for surfacing and implementing improved safety practices.
- Responsible for following all applicable waste handling procedures.
- Completes required paperwork / documentation accurately, neatly and in a timely manner.
- Effectively communicates with and proactively assists other associates as needed; anticipates and communicates effectively to prevent problems from occurring.
- Interacts with and/or participates on cross-functional product development teams.
- Responsible for the proper disposal of hazardous waste into the proper labeled containers and drums.
- Serves as back-up for QC Lab Supervisor (when needed).
- Make identifiable and substantial contributions to continuous improvement. Performs all duties consistent with established the company guideline consistent with all regulatory requirements. Actively complies with and endorses Department and Company objectives.
- Requires a Bachelors (or higher) degree in Chemistry or closely related discipline (Analytical Chemistry preferred) plus a minimum of 10 years related experience.
- Expert and proficient in application of gas chromatography (headspace, high-pressure liquid & gel permeation), UV-VIS-FTIR spectroscopy, TOC, thermal and mechanical analysis (e.g. DMA, DSC, etc.), wet chemistry techniques, etc.
- Extensive knowledge and understanding of scientific principles involved in the performance of analytical test methods.
- Extensive analytical method development, transfer, qualification, verification and validation experience for drugs and drug products.
- Must have above average computer skills and knowledge; specifically in the operational use of analytical equipment having a computer interface.
- Knowledge of requirements for maintaining proper laboratory notebook documentation.
- Ability to read and interpret documents such as test methods and procedure manuals.
- Ability to troubleshoot and perform basic maintenance to ensure optimum performance of instrumentation.
- Ability to apply basic statistical process control concepts such as control charting.
- Ability to efficiently utilize time (coordinate several assignments concurrently).
- Good communication skills (verbal and written) and interpersonal skills.
- Requires common physical characteristics and abilities, such as above average agility and dexterity; physical exertion such as long periods of standing, recurring bending, crouching, stooping, stretching, reaching or similar activities should be expected.
- Work environment involves moderate risks or discomforts requiring special safety precautions, will be required to use personal protective equipment.