Associate Director, Pharmaceutical Development
Wolfe Laboratories, Inc. is a premier Contract Research and Development Organization located in Woburn, MA. We are currently seeking an Associate Director of Pharmaceutical Development to support the rapid growth of our organization. Reporting to the Vice President of Pharmaceutical Development, this role will be critical to both the management of drug development projects as well as the supervision of a diverse set of scientists. We are looking for an experienced scientific manager with a solid understanding of the analysis and formulation of small molecules and biologics as well a good working knowledge of the drug development process. The position is critical in the operations of the organization and management of client drug development projects.
Responsibilities will include, but are not limited to, the following:
- Technical direction of pharmaceutical development projects which can range from preclinical stage to commercial readiness covering preformulation, analytical method development, dosage form design and development, stability evaluation, bioanalysis, preclinical/non-clinical drug product manufacture, assay qualification/validation, and technology transfer
- Lead high performing technical project teams composed of pharmaceutical scientists, chemists, and biochemists who are cross-functionally integrated with colleagues across departments
- Provide oversight, direction, and supervision of a group of individual scientists
- Preparation of high quality development proposals including associated budgets, timelines and milestones based on client needs
- Execution of client projects by securing resources, development of plans, design of studies and management of timelines, budgets and communications.
- Create, promote, and improve technical capabilities and related workflows for the Pharmaceutical Development area
- Acts as CMC reviewer and subject matter expert support relevant regulatory submissions and acts as a subject matter expert during client interactions
- Participate in risk assessment, financial and strategic planning, and project guidance to protect the Company’s interests and resource investments
- Build and maintain strong working relationships with relevant functions (including Small Molecule Development, Biopharmaceutical Development, Project Leadership, Business Development, Technical Operations, Quality, as well as clients and CRO/CMO partners), ensuring that activities are managed collaboratively, efficiently, and effectively
- Perform other duties as necessary
Leadership and Management
- Manage a group of up to 8 direct reports
- Develop staff through coaching, training, and other relevant experiences resulting in high performing teams
- Identify departmental needs and recruit/hire/promote personnel as appropriate
- Reinforce Wolfe Laboratories’ culture and values, and drive change where needed to increase alignment with those goals
Project and Portfolio Management
- Operate effectively in a multi-tasking, cross-functional environment
- Develop appropriately proactive resource plans and utilize staff and other resources effectively to meet clients’ needs through initiation and management of projects.
- Regularly review, measure, and adjust plans to ensure efficiency, effectiveness, and balance of resources according to evolving business needs and environment
- Clearly communicate project information to management team, including status, issues, changes, etc.
- Guide internal/external debate and discussions at high levels and focuses constituents towards resolution around strategic and tactical decision making
- Display strong analytical and strategic thinking
- Provide constructive and timely feedback and coaching to enhance personnel performance
- Coach employees on long term career development and leadership capabilities
- Guide the reallocation of roles and responsibilities across team members to facilitate both goal achievement and personal development
- Practice good decision making and assess and reward behaviors consistent with good decision making practices
Required Background and Experience:
- 10+ years of relevant experience in the analytical and formulation development of pharmaceuticals
- Proven track record of scientific and leadership responsibilities including successful project management required
- Demonstrated technical proficiency with at least one pertinent class of drugs (small molecules, peptides, proteins, nucleic acids, antibodies, antibody-drug conjugates)
- Experience in biopharmaceutical development, lyophilized formulation development, parenteral formulations or novel dosage form design a plus
- Excellent communication, interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators) required
- PhD in Pharmaceutics, Pharmaceutical Science, Organic Chemistry, Analytical Chemistry or related scientific discipline required
- Sound knowledge of related aspects of pharmaceutical research, development, and commercialization processes
- Established knowledge of applicable global drug development and regulatory standards including cGMPs
- Experience preparing technical sections of regulatory submissions and interacting with regulatory authorities on technical matters a plus
- Excellent written and verbal communication skills
Interested candidates are requested to email a copy of their resume with a cover letter including salary history and unofficial transcripts.
Wolfe Laboratories, Inc. (WLI), located in Woburn, MA, is a premier contract research organization that provides integrated early drug development solutions to the biopharmaceutical industry. Wolfe Laboratories is an essential element of the drug development ecosystem, recognized by global and virtual biopharmaceutical companies as a science-driven organization whose mission is to provide outstanding discovery and development services tailored to its clients’ needs for rational formulation development. Wolfe Laboratories integrates the critical path components of early development to ensure that programs advance while meeting rigorous scientific demands with flexibility to address dynamic challenges and aggressive timelines. Wolfe Laboratories’ vision is to improve human health, and we continue to strive towards that goal by embracing our core values of integrity, excellence and teamwork. The company has a high percentage of repeat clients, which is a testament to its long-term commitment of continual investment in its capabilities to meet biopharma’s growing demand for high quality, integrated early development services.
For more information visit us at: www.wolfelabs.com
Wolfe Laboratories, Inc is an Equal Employment Opportunity employer.