Sr. Scientist (Formulation) - PAD

Purdue Pharma L.P.•Durham, NC

61d

About The Position

Imbrium is a clinical-stage biopharmaceutical company dedicated to advancing medical science through the development of important new pharmacologic and biologic therapeutics. We are pursuing oncology chemotherapeutics, treatments for disorders of the central nervous system, and non-opioid approaches to the management of pain. As an operating subsidiary of Purdue Pharma L.P., Imbrium strives to develop and bring to market new medicines that serve the unmet needs of patients, physicians and health systems worldwide. We have built a robust and diversified pipeline of investigational drug candidates, and we actively collaborate with industry and academic partners to identify and advance future impactful medicines. At Imbrium Therapeutics L.P., you have a unique career opportunity to work differently, uncover and seize new opportunities, and take a hands-on, ownership approach to your work. We go beyond traditional roles and find creative ways to extend our skills and interests, challenging ourselves to contribute in different, meaningful ways. We welcome the opportunity to have you on our team! We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines. We are building an exciting path forward, we strive to create an environment where everyone can bring their best and true self to work each day. Embracing different backgrounds, ideas, and viewpoints are valued and encouraged. We believe that Respect grounds in our Values: Integrity andCourage, underpinned by Innovation, and always in Collaboration with each other. Together we make an impact on our growth, our culture, and most importantly, patients. Job Summary Responsible for providing formulation and process development leadership for the generic and branded development portfolios. Represents the department on project teams and is responsible for proposing development strategies, designing experiments, organizing/tracking data to draw independent conclusions and proposing the next steps. Leads development activities for a variety of dosage forms (primarily solid oral); conducts complex laboratory experiments; and processes and compiles results and conclusions without supervision. Responsible for recommending new and innovative strategies, generating and reviewing written reports; and providing technology updates to the department. Responsible for new product development, clinical supply support activities, scale-up/manufacturing development, packaging assessment, product transfer to Operations (internal projects) and/or third parties (external projects), and formulation/process optimization. Responsibilities may include product lifecycle development, new product portfolio support, and generation, review, approval, and oversight of third-party development.

Requirements

Bachelor of Science degree required (with 10+ years relevant experience)
Master of Science (with 8+ years relevant experience) or PhD (with 4+ years relevant experience) highly desirable
In depth experience in the fields of Pharmaceutical Product Development and/or Process Development
Detailed knowledge of solid oral dosage forms, formulation development, process development techniques, cGMP regulations, FDA and DEA regulations, and recent trends in FDA approaches.
Experience with pharmaceutical manufacturing equipment, and ability to supervise batch manufacture and instruct production operators, if needed.
Thorough knowledge of Pharmaceutical unit operations, primarily as it relates to solid dosage forms, liquids, creams, ointments, transdermal delivery systems, and combination products; capable of competent scientific judgments; proficient understanding of the formula/process/system to be studied.
Excellent written and verbal communication skills.
Ability to respond decisively to changing circumstances without delay during development, DOE, and batch manufacture; demonstrated problem solving skills; ability to be innovative, agile and collaborative.
Technical project management skills; above average competencies with Microsoft Office tools.
Detail oriented, self-motivated with strong problem-solving and time management skills.
In-depth knowledge of industry guidance and awareness of regulatory issues; maintain good laboratory practices in compliance with safety and environmental requirements.

Responsibilities

Serve as the technical lead for the formulation and process development, clinical supply strategy, manufacturing, product transfers, and scale-up batches of new products and processes, including batch record review, protocol generation/review, supervising batch manufacture, deviation review/approval, generation/review and support of regulatory documents (IND, ANDA, NDA) and deficiency responses with CDMO, etc.
Development of potential product/process activities for new products; present proposals to optimize formula and product flow.
Provide technical expertise to other departments, as needed, to solve problems; including troubleshooting active products, potential rework procedures for failed batches, or providing general SME expertise as requested.
Evaluate new products candidates which may require collaboration with Clinical, Regulatory, R&D, third-party manufacturing sites (CMO/CPO) and Quality to ensure proper development of new products; responsible for coordination of all activities within laboratory area and pilot plant.
Evaluation of SOWs for development and tech transfers (as needed).
Coordinate, develop, review and approve protocols for process/product development for internal and external projects.
Prepare reports, including data analysis, conclusions and recommendations.
Effectively communicate progress, plans and project status, results, and share advice and perspective on future activities; collaborate positively with other lab scientists and influence others through successful negotiation and conflict resolution.
Hands-on troubleshooting of product attributes (formula, methods, manufacturing, procedures, etc.) and production equipment involved in the manufacturing process (such as high shear granulators, fluid bed processors, solution prep systems, weighing systems, milling systems, blending systems, tablet compression machines/encapsulators, bead coating, etc.), following all applicable SOP’s, safety standards and procedures.
Provide accurate and reliable data; maintain laboratory records and documentation in compliance with Good Laboratory Practices.
Exhibit a high degree of independence in managing tasks and activities within area of responsibility. Complete assignments within expected timeframe and with minimum supervision.
Follow regulations, policies and guidance pertaining to workplace safety, health, and environmental practices.
Assist, mentor, and train other colleagues as requested.