Open Positions at Putney
Senior Director / Director, Business Developmment
Putney is seeking an experienced business development leader to manage and support all business development aspects of a rapidly growing generic drug company. Primary responsibilities include: API sourcing, business partner identification, partner selection, and deal execution.
In conjunction with VP of Strategic Portfolio Planning, successful candidate will develop/build/foster relationships with third parties and leverage those relationships to identify potential partners for API, finished dose formulation/development, and finished dose manufacturing. They will conduct diligence to select partners, negotiate business terms, and manage contracts to execution. They will analyze API needs and optimize API supply base by achieving the right combination of quality, speed, reliability, and cost. They will assist VP of Strategic Portfolio Planning in financial modeling, specifically understanding key assumptions including upsides and risks. They will work closely with cross-functional team to solicit input on partner capabilities, partner GMP compliance, and technical details of any proposals/deals. They will work with Product Development team to smoothly transition products from deal to project initiation.
Director of Regulatory Affairs
Putney is a pharmaceutical company based in Portland, ME which specializes in providing high quality generic drugs for pets where cost is a barrier to prescribing, compliance or use. Putney's current pipeline includes orals, injectables, liquids and semi-solid dosage forms.
Putney is seeking an experienced Regulatory Affairs professional to be responsible for the compilation and submission to CVM of generic animal drug applications with focus on high quality and meeting timelines. The Director will work closely with Product Development and serve as a regulatory liaison to communicate submission requirements to worldwide development and manufacturing partners. The Director will proactively interact with CVM to determine applicable regulatory requirements and will predict possible application deficiencies to enable resolution prior to submission.
In conjunction with the VP, Regulatory and Counsel, the Director will develop product-specific regulatory strategies. The Director will provide regulatory guidance and training to Putney team members and external partners, and advise Marketing regarding labeling and promotional requirements. The Director will serve as regulatory liaison to manufacturing partners for adverse event reports and quality complaints.
The Director will be a member of an 8-10 person Product Development and Regulatory Affairs team and will report to the Vice President, Regulatory and Counsel.
The Director must be an excellent communicator and team player, with good regulatory issue-spotting and problem-solving skills. The Director will have at least 8 years experience in Regulatory Affairs for generic or brand, human or animal drugs, with hands-on experience compiling drug applications. The Director should have at least 2 years additional experience in R&D, QC, Manufacturing, or another area of pharmaceutical development and marketing other than Regulatory Affairs. Additional experience in QA/cGMPs and in multiple dosage forms is desirable.
International and domestic travel required.
Senior Manager / Director, Quality Assurance
The position of Sr. Manager/Director, Quality Assurance provides a unique opportunity to help build the quality systems of a fast-growing early stage company and play a crucial role in reducing risk in outsourcing development and manufacturing activities to third parties.
Putney is seeking a Sr. Manager/Director, Quality Assurance to be responsible for creating, implementing, and overseeing additional Putney quality systems. Putney accomplishes drug development and manufacturing through third party partners and contractors and therefore, the Sr. Manager/Director will be responsible for QA aspects of qualifying these third parties, as well as monitoring for continued compliance in their quality systems and batch-to-batch commercial manufacture. Example activities for which the Sr. Manager/Director will be responsible include leading Putney’s internal and external audit program, reviewing and approving Quality Agreements, reviewing quality complaint investigations and manufacturing deviations, and assessing risks associated with contractor receipt of 483 observations.
The Sr. Manager/Director will be a member of an 8-10 person Product Development and Regulatory Affairs team and will report to the Vice President, Regulatory and Counsel.
The Director must be an excellent communicator and team player, with the ability to proactively address and lead resolution of compliance issues internally and with external partners and contractors. The Sr. Manager/Director will have at least 8 years experience in Quality Assurance for a human or animal drug company, and will have substantial knowledge of cGMP requirements for multiple dosage forms, along with prior experience with supplier qualification. Additional experience with GDPs and/or GLPs is desirable.
International and domestic travel required.
If interested email careers@putneyvet.com
Manager, Non-Clinical Studies
The Manager of Non-Clinical Studies will be a critical part of Putney’s highly collaborative, Product Development and Regulatory Affairs team. The Manager will report to the Vice President, Product Development and will be responsible for the execution of non-GLP and GLP bioequivalence studies in dogs and cats at third party CROs, including the oversight of the bioanalytical and statistical aspects of those studies. The Manager will be hands-on, have a commitment to ensuring that data are correct and be excited about the on-time delivery of multiple, concurrent, high-quality studies. The successful candidate will be not be afraid to challenge the status quo and be flexible enough to deal with the rapid progress in this field. We are looking to attract the “Best and the Brightest”: a driven individual excited about making a difference in the lives of pets and their owners!
Manager Product Development
Putney is a pharmaceutical company based in Portland, ME which specializes in providing high quality generic drugs for pets. Putney is a virtually integrated organization that uses CRO’s, CMO’s and partnerships around the world to develop oral, injectable and topical dosage forms for the veterinary market. The position of Manager, Product Development provides a unique opportunity to play a crucial role in optimizing the development and commercialization activities of Putney’s rapidly growing product pipeline.The Manager will be a member of the Product Development, Quality Assurance and Regulatory Affairs team and will report to the Director, Product Development. The Manager will be responsible for the close and effective coordination and tracking of CRO/CMO analytical activities under tight program timelines with cross-functional accountability and interdependence. The ideal candidate will leverage existing experience to manage analytical activities for many of Putney’s active projects from API synthesis through to finish dose form at all stage of product development (development through registration and up to commercial stage).
Veterinary Services Manager
Putney, a Portland, Maine based company focused on companion animal pharmaceuticals, is currently hiring for the position of Veterinary Services Manager. The Veterinary Services Manager will be responsible for technical and professional support of Putney's companion animal pharmaceuticals in collaboration with the customer service, sales, marketing and regulatory affairs teams. Candidate must have a degree in veterinary medicine and five years' veterinary practice experience; prior industry experience desirable. Key responsibilities include: responding to medical and technical questions (including adverse event reporting in collaboration with the Regulatory Affairs team); developing and delivering CE presentations; and supporting sales and marketing efforts. Interested candidates can send their resume/CV to careers@putneyvet.com
Associate, Product Development
The Associate of Manager of Product Development will assist Putney’s Product Development and Regulatory teams by supporting manufacturing, bioequivalence, project management and administrative activities. The Associate will report to the VP, Product Development. The Associate will be eager to get and keep things under control; organized, detail oriented with a commitment to ensuring projects are completed correctly; willing to work on multiple concurrent projects; and interested helping out wherever expertise allows.