Associate Chemist I
PharmaBiotechClinical ResearchRegulatory AffairsQuality Assurancegmpcdmregulatory submissioninformaws
Job description
About Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. Job Summary The Associate Chemist I provides analytical and technical support to new product development and completes analytical testing and various laboratory support functions in a timely manner according to cGMP's. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Reads, understands and follows the current USP/NF, laboratory SOPs, analytical methods and study protocols. Documents equipment usages and analytical results in a manner that can be readily followed by reviewers and is consistent with cGMP and in-house SOPs. Performs analytical testing according to established or preliminary methods such as cleaning validation samples, dissolutions, assay, impurities/degradation products, content/blend uniformity, pH, viscosity, titrations, general USP testing, residual solvents and other analytical methods. Proactively assists others with laboratory activities, such as, but not limited to, dissolution testing setup and cleanup, bulk solution and reagent preparation and stability sample labeling. Documents with clear purposes, sequences and conclusions per GMPs. Takes ownership to assigned work and critically reviews it prior to distribution within the functional group. Prioritizes assigned tasks and AIP goals based on work group needs with supervision. Is able to effectively plan work and utilize discretionary time so that assigned duties are completed in a timely manner. Reviews raw data timely and ensures it meets cGMPs and in-house SOPs, is scientifically sound and can be readily followed by auditors. Gathers source documentation or summary data required for regulatory submissions or technical reviews. Maintains personal and shared work space in an organized manner. Cleans laboratory glassware and actively participates in lab-wide routine clean up and inspection activities. Actively participates in continuous improvement efforts associated with laboratory operation. Works closely with supervisor or designee to complete assigned tasks and advance skills. 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. Required Education, Experience & Skills A Bachelor's Degree in Chemistry or related field with 12 credits of college chemistry, preferably in the pharmaceutical industry. Knowledge of analytical chemistry, good verbal and written communications skills. Ability to work independently, with others and to multitask. Good problem-solving skills. Compensation Range $74,000 - $80,000 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 Core Values At Bora, our values guide everything we do — from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone. Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.
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