General Summary:

Provides analytical and technical support to CDMO product development and technology transfer in a high-pace flexible environment. Completes method development, validations, USP/NF method verification, method transfers, and various laboratory support functions. Provide essential analytical support to various projects, ensuring revenue growth, lab capability enhancement, and quality compliance. Provides effective communication to the analytical team and applicable cross-functional groups to ensure proper coordination of program management. Provide coaching and mentoring to junior chemists.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Responsible for development and validation of assigned analytical methods such as assay and impurities/degradation products, residual solvents, content/blend uniformity and dissolutions.
• Author method development reports, method validation protocols/reports, and method transfer protocols/reports. Execute method validation/transfer testing.
• Develops robust methods that are time tested in a routine quality control environment.
• Leads method troubleshooting and rectifies challenges effectively using a variety of techniques including advanced principles and concepts.
• Assesses incoming methods from clients and ensures compliance with current applicable guidance's and BPI internal practice/procedures.
• Ensures robust method transfer strategy to ensure adequate method performance at BPI (or receiving lab).
• Reads understands and follows the current USP/NF, laboratory SOPs, analytical methods and study protocols.
• Applies applicable ICH and FDA guidelines to analytical method development, validations, and transfers.
• Assists with establishing specifications for APIs and drug products. and assists with justification of these specifications to be included in regulatory submissions.
• Documents equipment usages and analytical results in a manner that is consistent with cGMP, in-house SOPs, and can be readily followed by reviewers.
• Proactively identify, communicate, and escalate risks or issues to laboratory management and cross-functional teams to minimize project impact.
• Reviews raw data timely and ensures it meets cGMPs and in-house SOPs, is scientifically sound and can be readily followed by auditors.
• Shows expertise with analytical instruments such as HPLCs, GCs, dissolution apparatus, and other analytical equipment. Actively solves instrumentation issues and assists others with instrumentation startup and troubleshooting Maintains personal and shared workspace in an organized manner.
• Cleans laboratory glassware and actively participates in lab-wide routine clean up and inspection activities.
• Identifies potential training, efficiency, compliance and and/or safety concerns and brings solutions to management. Actively participates in and leads the implementation of continuous improvement efforts associated with laboratory operation.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Experience Type:

• A Bachelor's Degree in Chemistry or related field with 12 credits of college chemistry and 6 years analytical experience, preferably in the pharmaceutical industry, OR, a MS degree with a minimum of 4 years' experience OR a Ph.D. with a minimum of 1 year experience in analytical method development in a drug product pharmaceutical industry.
• Knowledge of analytical chemistry, strong verbal and written communication skills.
• Ability to work independently, with others and to multitask.
• Highly motivated and self-driven individual with ability to work independently, and multi-task, adhere to aggressive timelines in support of department and company objectives.
• Advanced knowledge of analytical techniques, including HPLC, GC, dissolution, and FDA and ICH guidelines. Experience with method development and method validation in a cGMP lab environment, PC's, cGMP's , and USP testing.
• Proven problem solving and leadership skills.

Other Skills / Abilities

• Knowledge of the concepts involved in various test procedures in order to evaluate the reliability of obtained results.
• Ability to write new procedures clearly and concisely which are easily understood, communicate clearly and effectively on technical concepts and rationales.
• Good organizational and analytical skills.
• Computer skills and experience with related software (Empower 3, Biovia a plus).
• Deals with changes associated project needs, directions, and processes without being negatively impacted in productivity and efficiency.

Compensation Range

$88,000 - $125,000

Compensation and Benefits

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer matching contributions
• Paid time off
• Professional development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and Mental Health Resources