Job Title: MSAT ScientistJob Description Partner with the Company Team including Manufacturing, Quality, AD/QC, Regulatory, and PD as a manufacturing 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 locations. Drive GMP compliance and evaluate all aspects of ongoing production, understanding when to intervene and when to escalate significant issues. Collaborate closely with the CDMO and internal teams to support manufacturing investigations and change controls. Assess product and process impact, identify root causes, and develop appropriate action plans. Review and approve CDMO manufacturing documentation and communicate routine production status to stakeholders. Author key technical documentation supporting manufacturing activities and contribute to regulatory submissions. Responsibilities + Provide direct Person-in-Plant on-site support during critical cell culture, purification, and drug product unit operations at CMO production locations. + Drive GMP compliance and evaluate ongoing production, intervening when necessary and escalating significant issues. + Collaborate with CDMO and internal teams to support manufacturing investigations and change controls. + Assess product and process impact, identify root causes, and develop appropriate action plans. + Review and approve CDMO manufacturing documentation including bill of materials, master batch records, and production record reviews. + Communicate routine production status to company stakeholders and assist with process data retrieval, processing, and analysis. + Author technical documentation such as risk assessments, manufacturing protocols, campaign reports, and descriptions of manufacturing processes and controls. + Contribute to the CMC manufacturing content of various regulatory submissions. Essential Skills + Managing projects in the pharmaceutical industry + Knowledge of cGMP, GDP, GCP, and ICH guidelines + Experience with external suppliers and partners + Process development and pharmaceutical manufacturing for biologics including cell culture, purification, and fill/finish operations Additional Skills & Qualifications + Experience in working with 3rd party GMP manufacturing + Experience with change control and deviations + Strong understanding of manufacturing processes and process improvement + Production management experience Work Environment This role requires up to 25% travel, mainly to 3rd party vendors. The work environment is dynamic and involves collaborating with external manufacturing partners (CMO/CDMO) and various internal teams. The company is patient-focused, founded by those directly impacted, and committed to improving the daily lives of patients living with devastating diseases. Pay and Benefits The pay range for this position is $48.00 - $62.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Feb 7, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.