Principal Scientist, MDI Formulation
Job Locations :US-FL-Coral Springs
More information about this job:
Lupin Pharmaceuticals Inc. is a specialty pharmaceutical company marketing generic and branded pharmaceutical products as
well as Active Pharmaceutical Ingredients (APIs) from its sales and marketing headquarters in Baltimore, MD.
Lupin Inc. has established a new Research and Development Center in the US located in Coral Springs, FL. This center will focus on the development of generic and branded pharmaceutical products.
Independently conducts, leads and supervises standard and advanced laboratory activities including evaluation and
selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.);pre-formulation, formulation and process development studies for pressurized Metered Dose Inhalers (pMDIs)following cGMP, Lupin EH&S and other relevant guidelines. Leads the development and evaluation of new formulation technologies where required. Initiates investigations and data reviews, plans formulation resources, and supervises, coaches and trains junior scientific staff.
- Independently conduct, lead and supervise standard and advanced laboratory activities for the development of pressurized Metered Dose Inhaler (pMDI) formulations following cGMP, EH&S and other relevant guidelines of Lupin, FDA and other governing bodies.
- Independently design and lead pre-formulation, formulation and process development studies to recommened selection of APIs, excipients, packaging material and manufacturing process.
- Independently design and develop manufacturing processes and conduct manufacturing activities for pressurized Metered Dose Inhaler (pMDI) products. Possess good understanding of other inhalation technologies.
- Evaluate and introduce new technologies; be capable of generating new practical ideas; possess strong understanding of experimental design.
- Provide expert support for manufacturing related technical issues.
- Write protocols, reports, methods and standard operation procedures.
- Write regulatory submission modules and any other documents to support submission and product approval.
- Develop statistical design of experiments with minimal supervision.
- Develop and implement appropriate training programs for manufacturing activities across all respiratory development sites.
- Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Communicate effectively with team members and internal or external customers.
- Work and communicate effectively with other functional groups and across global respiratory R&D sites.
- Independently lead major project tasks.
- Establish and maintain effective relationships with team members.
- Conduct lab work in accordance with SOPs; follow Lupin safety rules and procedures.
- Comply with all Lupin Corporate guidelines and policies.
- PhD in Pharmaceutical Sciences or related discipline with 8+ years, MS with 12+years research experience in pharmaceutical or related field.
- Must possess expert knowledge of development and manufacturing of pressurized Metered Dose Inhaler (pMDI) products.
- Knowledge and in-depth understanding of global regulatory requirements as applied to orally inhaled and nasal products (OINDPs).
- Excellent understanding of USP methodologies and ICH guidelines. Deep knowledge of the FDA cGMP requirements as they apply to the Pharmaceutical industry.
- Strong English language skills including writing ability and oral communication. Experience with writing of CMC sections of regulatory documents (NDA, ANDA, IND, IMPD).
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law
click above to apply
now to Lupin Pharmaceuticals Inc