Associate Director, MS&T

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with the Company Team, which includes Manufacturing, Quality, AD/QC, Regulatory, and PD, serving as a manufacturing Subject Matter Expert (SME) for our clinical manufacturing processes. Provide direct Person-in-Plant on-site support during all critical cell culture, purification, and drug product unit operations at CMO production sites.

• Ensure GMP Compliance and assess all aspects of ongoing production, knowing when to intervene on behalf of the company and when to escalate more significant issues for resolution.

• Work closely with the CDMO and internal teams to assist with manufacturing investigations and change controls.

• Evaluate product and process impact, contributing to root cause identification and the development of appropriate action plans.

• Review and/or approve CDMO manufacturing documentation, which includes manufacturing bill of materials, production master batch records, and executed production record reviews.

• Regularly communicate production manufacturing status to company stakeholders and assist as necessary with process data retrieval, processing, and analysis through written, verbal communication, and presentations at various company meetings.

• Author key technical documentation that supports manufacturing activities, such as technical risk assessments, manufacturing protocols, campaign reports, and descriptions of manufacturing processes and controls.

• Create supporting documentation for relevant CMC manufacturing content for various regulatory submissions as needed.

⛳️ Requirements

• Bachelor’s degree in science, engineering, or a related field with over 10 years of experience in a pharmaceutical environment.

• Alternatively, an advanced degree (MS/PhD) with at least 8 years of experience.

• Proven experience managing projects within the pharmaceutical industry.

• In-depth knowledge and experience adhering to cGMP, GDP, GCP, and ICH guidelines.

• Experience collaborating with external suppliers and partners, including CDMOs.

• General understanding of process development and pharmaceutical manufacturing for biologics, including cell culture, purification, and/or fill/finish operations.

• Strong interpersonal skills with the ability to adapt to various personalities in a respectful manner conducive to achieving personal and team objectives.

• Exceptional communication abilities, both oral and written, including planning and conducting meetings and presentations.

• Capacity to multitask and manage multiple competing priorities and projects simultaneously in a dynamic, fast-paced environment.

• Strong analytical skills along with robust oral and written communication abilities, capable of functioning in new or unstructured environments.

🏝️ Benefits

• Competitive Health and Dental programs with flexible plan options, including FSA and HSA programs.

• Participation in a 401(k) program with competitive company-matched contributions.

• Eligibility to join Solid’s Employee Stock Purchase Plan.

• Mobile phone subsidy available for eligible employees.

• Tuition Reimbursement program.

• Vision Coverage included.

• Life Insurance provided.

• Voluntary Pet Insurance options.

• Employee Discount Program for Travel, Entertainment, and Services.

• Access to Employee Assistance Programs.

• Daily subsidized lunch delivery available (onsite @ Hood Park).

• Free onsite full-service gym (onsite @ Hood Park).

• Employee parking facilities (onsite @ Hood Park).

• 12 observed holidays and a winter shutdown period.

• 15-day PTO policy with a 40-hour rollover year over year.

• 40-hour sick leave policy.

• 8-hour floating holiday.