Director, External Manufacturing
- Waltham, MA, USA
Kala is a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary AMPPLIFY TM Drug Delivery Technology, with an initial focus on the treatment of eye diseases. Kala’s first approved is INVELTYS TM, the first and only corticosteroid for the treatment of inflammation and pain following ocular surgery. Kala’s lead pipeline candidate is KPI-121 0.25%, for the temporary relief of the signs and symptoms of dry eye disease, for which a New Drug Application (NDA) has been filed with the FDA and a target action date under the Prescription Drug User Fee Act (PDUFA) has been set for August 15, 2019.
Kala is an emerging pharmaceutical company on the verge of commercialization. We are seeking a Director, External Manufacturing to join the team! This is an opportunity for the right individual to come aboard and serve as Kala's manufacturing contact for external manufacturing sites. Come join an experienced and highly motivated team.
Key Responsibilities for this role will include:
- Primary focus will be on contract packaging partners and manufacturers of critical packaging components.
- Be Kala's technical expert for assigned contract manufacturers and suppliers. Coordinate and lead key activities such as packaging line trials, engineering batches, validation campaigns, process changes and scale-up.
- Work closely with the quality unit in reviewing and approving protocols, master packaging records, packaging component specifications, validation reports etc,
- Establish KPI’s with external manufacturing partners.
- Monitor and ensure supplier performance.
- Coordinate and manage regular business reviews with partners. Travel frequently to manufacturing partners to ensure alignment with Kala’s expectations.
- Coordinate internally to ensure seamless flow of information to and from manufacturing partners. Establish strong working relationships with Regulatory and Quality functions.
- Lead internal teams on key projects such as supplier selection and process improvements.
- Provide support as needed for regulatory filings.
- Provide planning and inventory management of critical manufacturing components at external manufacturing sites on an ongoing basis.
- Provide manufacturing support during critical campaigns (milling and filling) at external manufacturing sites as and when required.
- Minimum 10 years of experience technical and/or manufacturing for pharmaceuticals, biotech or medical devices.
- Knowledge of pharmaceutical packaging materials (primary and secondary) is required.
- Strong understanding of the challenges the manufacture of FDA regulated products is required. Knowledge of ex-US manufacturing regulations is desirable.
- Bachelor’s degree in a technical discipline is required. Advanced degree is highly desirable.
- Must have ability to communicate effectively and work collaboratively with all levels of the organization.
- Must be action oriented and willing to lead. Must have the ability to orchestrate and coordinate teams of internal and external stakeholders. Must have ability to thrive in a small and quickly growing organization.
- Must have strong working knowledge of best practices in pharmaceutical manufacturing.
- Must be willing to travel up to 40%.
Kala Pharmaceuticals is an Equal Opportunity Employer that offers a competitive and comprehensive employee benefits package