Pharmacist Job In Waltham, Massachusetts
Director, Drug Product TechnologyNext Steps... Apply Now
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US-MA-Waltham | US-PA-Wayne
Job ID 2019-1876
# of Openings 1
Category Pharmaceutical Development/Operations
Radius Health is searching for a Director, Drug Product Development, Tech Ops. with sound technical and leadership capabilities to develop our promising pipeline and support our commercial products.
Reporting to the Head of Pharmaceutical Sciences, the Director of Drug Product Development is accountable for the formulation and process development, scale-up and production of dosage forms for clinical trials and commercial drug products including drug product-device combinations. The individual we are seeking will have a well-established track record of successfully developing drug product formulations and processes through concept to commercialization across multiple modalities. In addition, the successful candidate will have demonstrated capabilities in working cross-functionally with internal stake holders and effectively managing development activities at external vendors.
The position holder needs to have a broad range of knowledge across the various functional areas in pharmaceutical development, understand manufacturing technologies, people and organizational structures. The role enables high performing internal and external development teams to successfully develop, commercialize, and file products. In addition, this role will oversee the development of peptides, small molecules, injectables, solid dosage form, and transdermal devices with associated analytical methods.
Key responsibilities include leading the development, scale-up, validation and registration of drug products and drug-device combination within the Radius portfolio, managing drug product development activities at external vendors in accordance with applicable regulatory and quality requirements and working closely with internal project teams to ensure drug product development activities and timelines are aligned with project and corporate goals.
- Ensures appropriate technical, scale-up, validation and production strategies/timelines are in place for drug product and drug-device combinations to meet the programs clinical supply and registration needs in accordance with corporate goals
- Manages drug product development activities at external vendors including providing input into the design of experiments, managing timelines, reviewing technical and batch manufacturing documentation and ensuring that Radius's business needs are met by the vendor
- Implement Quality by Design (QbD) principles in drug product development programs including technical risk assessments, identification of critical quality attributes and process parameters, and manufacturing control strategies
- Prepare pharmaceutical development reports and other technical documentation required for regulatory submissions, including authoring, review and approval of requisite sections of the IND, CTA, IMPD, NDA, MAA or other filings
- Work collaboratively within Technical Operations and across internal stakeholder functions such as Project Management, Clinical and Regulatory to meet program goals, including representation on CMC development teams and corporate product development teams where required.
- Work closely with Analytical Development to ensure that appropriate methods are in-place for the characterization and release of drug products, and supply chain to ensure that drug product is available for clinical and commercial use in accordance with project timelines
- Provide input into the preparation, maintenance and tracking of budgets and timelines associated with drug product development activities
- Ensure that all work is conducted in accordance with applicable Radius policies and procedures, CGMP and regulatory standards and guidelines.
- Participate in evaluating licensing and due diligence opportunities.
- Lead and participate in strategic initiatives for improving functional process within Technical Operations
- Maintain an understanding of current laws & regulations applicable to the pharmaceutical/biotechnology industry
- PhD. in Pharmaceutical Sciences or related discipline with at least 10 years of relevant experience in pharmaceutical development and validation
- Experience in successfully leading drug product development and manufacturing activities at external vendors
- Experience in combination products or devices is a plus
- Knowledge and experience of applying QbD principles to the design and manufacture of drug product formulations and processes
- Strong project management skills and the ability to prioritize and align drug product development activities with broader project goals
- Flexible, adaptable and collaborative style with a willingness to take on new challenges and positively respond to changes
- Knowledge of current regulatory guidance's and experience in managing IND and NDA filings
- Excellent interpersonal, technical writing, and oral communication skills.