Associate Director, Drug Product and Formulation Development

Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation.

We don't follow footsteps. We create the path.

Primary Duties

The Associate Director, Drug Product and Formulation Development will lead the development and implementation of drug product for various modalities to support Spark's expanding gene therapy pipeline.

A successful candidate will participate in defining formulation and drug product strategy, collaborate closely with research, internal and external analytical and drug substance teams, and experts, and lead the design and implementation of drug product development workflows including developability, formulation, and compatibility development. The role will include oversight of laboratory implementation of formulation development workflow design and testing and training of users across tech dev and in particular DS and DP groups. The candidate must have knowledge in both drug product, drug substance and formulation development and be a strong collaborator to work within function as well as across the Technical Development organization to help drive an integrated data management strategy. The goal is to establish end to end solutions for formulation development, including experiment design, data management, data visualization and analysis, process modeling and result reporting. Essential to this role are strong communication and leadership skills, as well as experience in leading technical teams. The role manages a team of formulation development scientists to achieve business goals and objectives.

Responsibilities

Lead formulation development and implementation of drug products for pipeline projects as well as new modalities coming from discovery. Collaborate closely with internal and external groups on advancing pipeline during early and late-stage development. Support resolution of technical issues during formulation development, in-use studies, and related drug product process development. Lead commercial formulation development. Author drug product sections of regulatory documents related to formulation and process development. Support combination product development. Support drug product development studies and be the lead for early DP development projects.

Define and drive the advancement of formulation technology roadmap for both viral and non-viral products. Collaborate with Research groups on pre-formulation development and developability of early candidates. Constantly evaluate most recent scientific and technology advancements in the field of biologics formulations. Implement new formulations with advanced stability properties. Implement automation and high throughput technology in viral and non-viral formulation development. Define formulation platforms for existing and new modalities.

Manage team of formulation scientists and associates to achieve business goals and objectives.

• Foster Spark's Culture. Role model the Spark Values. Create an environment where team members thrive by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that "how" they achieve performance objectives is just as important as "what" they accomplish.
• Hire & Integrate. Know what skills, experiences and capabilities are needed to achieve current and future business goals. Take an active role in attracting and selecting talent who are inspired by our Mission, Vision, and Values. Consciously create a team with diverse backgrounds, experiences, skill sets and perspectives. Help new team members successfully integrate into Spark so they can actively contribute and add value as quickly as possible.
• Manage performance. Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing. Provide team members with continuous and on-going performance feedback, holding everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by continuously communicating priorities, decisions, and changes; adjusting goals as needed.
• Develop people. Understand each individual team member's career goals. strengths and motivators. Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on-the-job experiential learning and stretch opportunities.

Education and Experience Requirements

• PhDin bioengineering, chemical engineering, biochemistry, or related discipline with 5+ years of industry experience, OR MS in related discipline with 10+ years of industry experience.
• 5+ years' experience in AAV or biologics formulation and/or purification process development in the biopharma industry is required.
• Good knowledge of statistical analysis applied to biologics characterization is preferred.
• Good knowledge of structural characterization of AAV is preferred.
• Good knowledge of Drug Product manufacturing process development is plus.

Key Skills, Abilities, and Competencies

• Able to self-direct toward individual milestones while leading a team toward project deliverables.
• Strong working knowledge of formulation development and implementation.
• Excellent writing and verbal communication skills.
• Proven strong collaborator and skilled at collaborating across multiple functions.
• Strong organizational skills and detailed documentation abilities is required.
• Must be comfortable in the fast-paced, multi-tasking biotech environment.
• Be able to think strategically and make disciplined decisions to address business needs based on priority.
• Demonstrate independent problem-solving skills when faced with technical issues; capable of working on multiple tasks and developing solutions for a variety of complex problems.
• Be able to seek out and collaborate with internal and external experts to develop innovative and practical solutions to problems.
• Position requires the candidate to be on site majority of time, and to wear PPE as required by lab SOPs.
• Due to the inherent nature of experimental work, some extended hours / weekend work may be needed on occasion.
• Although infrequent, some travel may be required.

Spark takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees.The base salary range for this position is currently from $117,700. to $176,500.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.