Associate Director/Director, Formulation/Drug Product Development

The Position:

The Associate Director/DirectorFormulation/Drug Product Development will report to the SVP and Head of CMC, is a critical role in our development team and will help lead the successful development and commercialization of Volastra's lead product candidates. Individuals who are self-motivated, enthusiastic team players with a passion for playing a key role in the development of life-saving medicines are encouraged to apply. Expertise and experience in small molecule formulation development and manufacturing, and CDMO management are required. Experience in large molecule/biologics drug Product Development is a plus. The incumbent will work with internal and external team members to meet Company timelines and objectives. Responsibilities include but not limit to drug Product Development, manufacturing, supply chain, procurement and distribution activities, as well as preparation of CMC sections for regulatory submissions and updates.

Volastra is a fast-paced biotech company of passionate employees, and there is substantial opportunity for the ideal candidate to grow and develop with the organization. Individuals will have the opportunity to work on projects and take on responsibilities that may fall outside his/her immediate scope of work.

The job is based in NYC with a flexible option for hybrid work. 

Essential Duties and Responsibilities:

• Be responsible for formulation development, process development, manufacture, release, stability, packaging, labeling, supply chain, logistics and distribution of portfolio drug candidates.
•  Design and develop phase appropriate formulations to support preclinical and clinical studies.
• Lead in RFP writing, technical transfer, process and method development, optimization, qualification, validation, and activities related to all manufacturing operations.
• Evaluate third-party manufacturers by working with Quality Assurance and Regulatory Affairs, negotiate effective supply/technical agreements.
• Identify and manage contract analytical laboratory site(s) required to guide and support third party manufacturing relationships. 
• Serve as the point person with contract manufacturing and testing labs.
• Work closely with contract manufacturers (CMOs), Supply Chain leads, Quality and operations partners to ensure supply continuity with optimal cost and quality. Ensures the supply chain and chain of custody are defined and maintained for all clinical supply activities.
• Build and maintain forecast/demand plans and production schedule to ensure supply and demand are aligned and kept current to evolving assumptions.
• Manage Interactive Response Technology (IRT) systems from specification, user acceptance testing and release to support randomization and management of CTM. Monitor shelf-life and expiry dating and coordinate retest extension (e.g. over-labeling) to ensure continuous supply.
• Manage investigation, reporting and communication of outcomes from temperature excursions, product complaints, etc.
• Design and oversee execution of drug product activities in preparation for registration and validation, and commercial activities.
• Manage and execute Primary/Registration batch manufacturing and stability activities aligned with regulatory filings.
• Participate in cross functional project teams for Product Development as CMC functional area representative.
• Author relevant sections of regulatory documents, including Investigator's Brochure, Pharmacy Manual, Study Protocols, IND and NDA filings and updates, IMPD, CTA, MAA, DMFs, etc.
• Track proposals and invoices to insure alignment with approved CMC budget.
• Ensures that key project milestones and schedules are met.
• Manage consultants, vendors, and CDMOs to meet agreed upon program timelines/budgets.
• Travel to various CDMO sites (20%)
• Other projects as deemed appropriate

Knowledge/Skills/Abilities Required:

• PhD or MS in Pharmaceutics, Pharmaceutical Sciences or related discipline and 7+ (MS 10+) years of hands on experience with increasing responsibility in pharmaceutical development.
• Experience in drug Product Development from early to late stages with oral dosage and injectable forms.
• A successful track record in selection and management of CROs/CMOs including site qualification, technical transfer, clinical supply logistics and oversight of activities.
• Small biotech experience is desired, large pharma experiences is a plus.
• In-depth knowledge and full understanding of GMP requirements and CMC regulatory requirements for drug candidates.
• Proficient in authoring and reviewing of the CMC sections of the regulatory dossiers.
• Strong understanding of pharmaceutical development, quality and regulatory issues.
• Ability to multi-task, prioritize, and time manage daily activities with high attention to details.
• Team player with strong project management, interpersonal, communication and presentation skills.
• Flexibility within a rapidly changing environment.
• Excellent ability to work in a goal and team-oriented setting.
• Well-developed organizational skills and ability to thrive under pressure.
• Management and supervisory experience preferred.

Salary Range:

Approximately $160,000-$210,000 per year, which may vary depending qualifications, experience and ultimate leveling.