Director, Downstream Process Development

Director, Downstream Process Development

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

Resilience is seeking a highly experienced and scientifically-driven Director of Downstream Process Development, who will lead the Downstream Process Development function for the Biologics, Vaccines, and Gene Therapy modalities. This leader will play a critical role in revolutionizing the way drugs are developed and manufactured at Resilience. Reporting to the Head of Process and Downstream Process Development – Biologics, Vaccines, and Gene Therapy, the Director of Downstream Process Development will be accountable for the flawless execution of the Biologics, Vaccines, and Gene Therapy downstream process development activities; spanning technical development, process transfer, manufacturing, product release and successful preparation of regulatory submissions. She/he will oversee and drive a team of downstream process scientists that manage the downstream process development-related activities for multiple projects. This leader will be responsible for driving a deeply scientific and customer enabling culture. A key aspect of the role will be the technical mentorship of the staff and the ability to raise their technical expertise through close interaction and mentorship. The successful candidate must have hands-on background in development and GMP implementation of recovery and purification operations; spanning the needs of the Biologics, Vaccines, and Gene Therapy modality.

The ideal candidate will work with the Head of Process Development - Boston, customers, and internal scientific leaders to design and implement technical strategies which deliver the latest scientific and Downstream Process innovations to our technical development and manufacturing infrastructure, network and client partners. We are seeking an experienced drug development leader to play a key role in coordinating and delivering successful customer and internal programs. This individual will be a team leader that motivates employees to execute our mission and nurtures the development of scientific talent into world-class drug development teams.

Job Responsibilities

• Be accountable for the flawless execution of customer projects from technical development, through manufacturing operations and culminating in the successful preparation of regulatory submissions.
• Provide technical, tactical, and scientific leadership to the team in the development, qualification, and implementation of innovative, robust, cost-efficient process capabilities that are clearly tied to business, client, and scientific requirements.
• Lead a team of technical staff and provide day-to-day support, career development and mentorship.
• Coordinate the alignment of the overall Downstream Process function, with other site PD leaders, to define work processes that maximize efficiency, predictability, and velocity.
• Provide input into the advancement of downstream process methods such as high-throughput screening, implementation of PAT technologies, and continuous/connected-DSP processing and their applications to the characterization of Biologics, Vaccines, and Gene Therapy products.
• Direct a seamless interface with operational teams to transfer in process capabilities and to address any problems or unexpected results in manufacturing.
• Interface with candidate clients to highlight company capabilities and approaches; author and provide critical technical feedback on client project proposals.
• Provide representation to CMC teams for collaborative client projects for strong communication, strategy setting, and execution.
• Collaborate with process and analytical development teams to ensure appropriate experimental design, sample analysis, and data interpretation.
• Lead the gathering and analysis of data trends including assay controls and batch-specific data.
• Direct authoring and review of technical and scientific documents, including (but not limited to): study protocols and reports, validation documents, SOPs, regulatory submissions, and test methods.
• Serve as a technical beacon for the team by maintaining expertise, reviewing publications, attending conferences and networking across other Resilience sites to support a downstream process development community of practice.
• Foster a culture of innovation and an environment of technical mastery at all levels.
• Collaborate with other site leaders to define work processes that maximize efficiency, predictability, and velocity.
• Manage resource allocation and set priorities and objectives for the team to ensure timely completion of client and internal technology development deliverables.
• Work closely and collaboratively with Process Development, Quality and Regulatory colleagues to establish highly efficient technology transfer and to reduce COGM, while significantly increasing operating efficiencies via designed process & analytical platforms.
• Assist in developing long-term strategies on science and technologies.
• Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team members.
• Ensure quality, quantity and timelines in all assigned projects and/or platforms.

Minimum Qualifications

• Thorough understanding of downstream development processes in Technical Development.
• Provide technical, tactical, and scientific leadership to the team in the development, qualification, and implementation of innovative, robust, cost-efficient process capabilities that are clearly tied to business, client, and scientific requirements.
• A leader of leaders with direct experience leading high-performing teams, who is passionate about mentorship, culture, and nurturing the development of scientific talent.
• Excellent communication/presentation skills and scientific/technical writing skills.
• Demonstrated successful experience with working in interdisciplinary and cross-cultural teams.
• Previous supervisory experience managing teams of downstream process scientists at various levels.

Preferred Qualifications

• PhD in Chemistry, Bioengineering, Chemical Engineering or a related discipline preferred, with deep technical experience in biomanufacturing/biotech/pharmaceutical.
• Proven track record of creativity, problem solving and productivity in projects, particularly when no or minimal precedent has been set.
• A recognized drug development leader, with breadth of exposure across the spectrum of CMC functional responsibilities.
• Consultative approach in partnering with customers to optimize solutions.
• Ability to convey mission and ideas to diverse audiences, including business development partners, and internal stakeholders.
• Appreciation for the design, organization and execution of a successful R&D approach and working knowledge of regulatory, commercial, and business aspects of the biotech industry.
• A track record of successfully developing drug candidates; introducing improvements to relevant processes or operations and/or devising novel solutions to problems that served as a roadblock.
• Ability to fluidly flex between high level strategy and detailed tactics and works well in the grey zone.
• Strong analytical mind-set and ability to quickly assess large amounts of information and distill into key messages and actions.
• Advanced coaching and mentoring skills.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $160,000.00 - $227,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

#J-18808-Ljbffr