Associate Director | Digital Prospectors Careers

Job’s Overview:

Digital Prospectors is seeking a Associate Director in Greater Boston. Please take a moment to read the job post below if you are interested:

Position: Associate Director (MSAT Upstream Process Development)

Location: Milford, MA (Onsite)

Length: Direct Hire

Covid Requirements: Covid vaccine required, subject to reasonable accommodations

Job Description:

Our client is looking for a “hands-on” Associate Director of MSAT Upstream Process Development. The Associate Director will provide a key leadership role, working in collaboration with stakeholders in Manufacturing, Process Science, Engineering, and Quality. The Associate Director will focus on developing the MSAT Upstream Process Development team capabilities to support clinical and commercial manufacturing for products. The Associate Director will report to the Senior Director of Process Science.

Essential Duties and Responsibilities (but not limited to):

• Lead technology transfer of products while working closely in collaboration with Process Development, Manufacturing, Engineering, and Quality.
• Partner with Process Science to ensure the design and scale up of processes, instruments, and equipment from the laboratory through pilot scale are executable by manufacturing operations when moving into full scale manufacturing.
• Partner with manufacturing to ensure that manufacturing operations are designed for success ensuring high quality batch records, robust processes, and new technology.
• Anticipate, respond to, and resolve issues that arise on the floor in production through use of master data, process, and product monitoring.
• Utilize MSAT team’s technical skills and process knowledge to participate and/or lead process investigations through to root cause determination.
• Collaborate within the organization to develop and execute effective CAPA.
• Own and proactively drive process performance qualification together with MSAT DSP, Process Science, Regulatory, Manufacturing, Validation, and Quality.
• Lead process monitoring and control of manufacturing processes and continuous improvement programs.
• Provide troubleshooting, technical support, and training on the shop floor.
• Regularly interact with senior management and clients (interactions involve use of influencing, conflict resolution, and balancing the interests of all parties involved).
• Work closely with clients to ensure that their projects are executed successfully through the transfer, implementation, validation, filing, and licensing of their products.
• Partner with MSAT network teams and peers to share and adopt best practices and drive continuous improvement in all technical aspects of production.
• Support the business development function by providing technical expertise for process facility fit evaluations and responses for RFPs.
• Responsible for authoring technical reports, manufacturing instructions, process validation documents, and portions of regulatory submissions to support licensing client products and process changes.
• Support regulatory filings and responses to health authority questions.
• Author and review CMC sections for IND and BLA submissions.
• Establish strategic goals and objectives that drive MSAT responsibilities, organizational performance, and team development.
• Accountable for budget and performance of MSAT Upstream Process Development team.

Qualifications:

• Bachelor’s Degree in STEM and 12+ years of related experience (Master’s degree and 10+ years of related experience or a PhD and 7+ years of related experience is preferred).
• 5+ years of work experience in pharmaceutical or related industry.
• Experience in bringing biotechnology equipment and processes from design through to clinical and GMP operations.
• 5+ years of leadership and management experience required with demonstrated ability to set vision and direction for a team including setting expectations and motivating for results.
• Technical expertise with Biologics drug substance process development and manufacturing operations.
• Experience in process transfer in fed-batch cell culture and manufacturing technical operations.
• Experience of bioprocess facility design.
• Experience with project management and/or leadership enabling cross functional engagement to deliver project goals and timelines.
• Experience managing a technical team or function inclusive of hiring and developing high performing colleagues.
• Experience with quality systems such as Deviation, CAPA, and Change Control Systems.
• Escalate and resolve project issues and roadblocks as appropriate.
• Ability to identify and resolve complex technical issues including quality investigations.
• In tune with the major technological trends in biotechnology.
• Proficient in Wonderware, JMP and/or MODDE, and Microsoft Office (Outlook, Word, Excel, and PowerPoint).
• Ability and proven track record of motivating, retaining, and developing key talent.
• Requires excellent interpersonal, investigative, and implementation skills.
• Ability to think strategically, strong business judgement connecting human resources with the business strategies and goals.
• Communicate a compelling vision and implement strategic plans for area of responsibility.
• Demonstrated influencing, relationship building, and effective facilitation and change management skills.
• Excellent communication skills with the ability to build rapport with management, employees, and customers.
• Ability to handle multiple tasks and provide the leadership to implement solutions to complex problems using the best available technology.
• Skilled in strategic thinking, communication, and negotiation with fast decision making to support the daily business.
• Ability to demonstrate flexibility, adaptability, and effectively work in a fast paced, rapidly changing CDMO environment.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Make this your next career move as one of our many long-term contractors or employees!

• Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) – OR – work as a W2 hourly contractor at a higher pay rate if you don’t need the benefit package.

Come see why DPC has achieved:

• 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice – Best Places to Work’ by Glassdoor
• Voted ‘Best Staffing Firm to Temp For’ four times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.

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Job #15782

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Applicants must meet the above-mentioned requirements in order to qualify for consideration to work as a Associate Director.

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