Process Development and Manufacturing Manager

SAB•Sioux Falls, SD

3d•Onsite

About The Position

The process development and manufacturing manager is responsible for managing process development and manufacturing associated projects supporting clinical and commercial manufacturing. Note: This is an onsite role. Some relocation assistance may be available.

Requirements

Master’s degree and 3+ years of relevant experience OR Bachelor’s degree and 5+ years of relevant experience
3 years of directly managing people in a highly regulated biologic/pharmaceutical manufacturing environment
5 years’ experience with biologic purification techniques including filtration, chromatography, UF/DF
5 years’ experience with biologic process intermediate assays including SEC, SDS-PAGE, bioburden, endotoxin, and ELISA
Strong time management and organizational skills
Critical thinker who can analyze and interpret data
Ability to manage and complete projects assigned
Ability to work independently with minimal supervision
Passion for continuous improvement
Collaborative manager with a cross-functional mindset able to work effectively with internal and external stakeholders at all levels
Strong written and verbal communication skills and the ability to effectively present information one-on-one, and in small and large groups.
Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook) as well as experience with project management software, electronic lab notebooks, electronic asset management, and AI tools preferred
Skilled in statistical analysis of data, to draw appropriate conclusions from development data.
Ability to wear a negative air respirator or powered air purifying respirator.
Ability to regularly lift up to 25 pounds and to also lift 50 to over 100 pounds with mechanical means. Specific vision abilities required by this individual include close vision, peripheral vision, and the ability to adjust focus.

Nice To Haves

Certifications or training associated with pharmaceutical development or manufacture preferred (e.g. risk analysis, visual inspection, aseptic processing, etc.)
Membership in industry organizations (PDA, ISPE, etc.) preferred

Responsibilities

Lead development and characterization of upstream and downstream manufacturing processes
Expertise in the definition of process parameters, raw materials, and manufacturing equipment
Participate in equipment and process design for scale-up and tech transfer
Collaborate with tech transfer teams for successful scaling of manufacturing processes
Responsible for department management, hiring, training, and coaching
Adherence to quality systems, SOPs, and batch records for GLP and GMP toxicology and clinical studies
Ensure continuation of equipment service contracts and internal equipment maintenance
Plan team schedule around process development and manufacturing activities
Coordinate activities with other departments to ensure seamless collaborations
Materials management activities, including following the vendor approval process as well as the material approval process and raw material dossier management
Other duties/responsibilities as assigned