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.
Essential Duties and Responsibilities: (Responsibilities include but are not limited to):
- 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
Supervisory Responsibilities:
This position has direct supervisory responsibilities
Education, Experience and Certifications:
- 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
- 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
- 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
Physical Demands/Working Conditions:
While performing the duties of this job, the employee is regularly required to walk, lift, stand, sit for extended periods of time and to lift arms above head for periods of time. This job requires an ability to work in a regular laboratory setting and an aseptic environment from time to time.
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.
Working Environment:
Duties will be performed in normal laboratory, ISO 7 or ISO 8 environment, and BSL2 laboratory settings. Occasional work in ab aseptic setting, ISO5 environment.
ADA:
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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