Location: Sellersville,PA, USA
Job DescriptionResponsibilities Coordinate with Project Management in the execution of development projects and with site groups for the introduction of new products. Comfortable working with external clients, to supplement internal expertise and methodologies, proven ability to recognize internal limitations and make recommendations to external clients. Interact with cross functional departments including Business Development, Project Management, ARD, QC, Technical Services, Quality Assurance, Operations and external clients. Develop formulation/manufacturing process from tech transfer to operations in support of GMP manufacturing. Apply and provide feasibility assessments for a variety of scientific principles and concepts to potential clients, products and investigations. Conduct experiments which increase the company understanding of products it manufactures or intends to manufacture and conduct literature searches to support formulation development. Assist, consult and troubleshoot during process transfer scale up and validation activities. Prepare and review documents to support projects, such as laboratory notebooks, protocols, reports, assessments, investigation reports, regulatory submissions, master batch records, change control, etc. Complete and document physical sampling/testing such as loss on drying, particle size distribution, bulk density, viscosity, pH, tablet weight, thickness, hardness, friability; sample for analytical and microbiological testing. Maintain the department laboratories, records, equipment and procedures in line with cGMP. Responsible to ensure that R&D activities comply with Quality and EHS requirements. Managing and protecting R&D assets as intellectual property. Budgeting and managing expenses. Develops strong, collaborative relationships with other departments/groups and fosters an environment of knowledge sharing. Keeps up to date with current trends and advances in Pharmaceutical sciences for liquids, semi-solids and oral dosage forms. Required Experience A minimum of 5+ years of experience for BS or MS and 3-5 years of experience for PhD. Pharmaceutical formulations development and processing experience in a wide variety of dosage forms, specifically, liquids, semi-solids and oral solid dosage forms. Experience in MUPS is a bonus. Experience in development, DOE, QbD, statistics and unique technologies is preferred. Preferred Skills Results oriented, driven and accountable Strong innovative, proactive, hands on orientation Collaborative and transparent, ability to foster teamwork o Ability to think strategically and execute on strategy Knowledge of investigational techniques such as RCA and risk assessment Effective research and problem-solving abilities Capable of managing multiple projects independently in a fast pace environment o Proficiency in Microsoft Office Suite programs QualificationsPhysical Requirements Lift up to 40 lbs. Able to work safely with heavy equipment. Regularly stand, walk, sit, use hands to finger, feel objects, tools, controls, reach with hand and arms, talk, hear, and good vision. Ability to climb ladders, bend, stoop, and kneel. Individual may be required to wear Personal Protection Equipment including N95 respirators and Powered Air Purifying Respirators. Not allergic to chemicals or bio-substances found in laboratory or production facilities.About UsIn the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.About the TeamPiramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.