Experience the Smoothest Path to Clinic
Scorpius Biomanufacturing is an innovation-driven contract research, development, and biomanufacturing organization offering clients a customized, integrated, end-to-end solution for their large molecule discovery research, process and analytical method development, cGMP manufacturing, product characterization, release testing needs, and clinical trial support. Our approach enables us to forge collaborative client relationships that move beyond the traditional service outsourcing model into full product development collaborations.
Reporting directly to the Vice President of Process Sciences, the Senior Director of Manufacturing Sciences and Technology (MS&T) will provide a leadership role in the scale-up, characterization, and transfer of biological processes from Development into Manufacturing. This individual will independently manage day-to-day activities, and maintain a collaborative work environment with Process Development, Analytical, Manufacturing, and Quality organizations as well as Program Management leaders. This Candidate must have experience with recombinant protein therapeutics (mammalian and microbial) and cell-based therapies. Additionally, Client-facing interactions are required during the program’s lifecycle. The ideal candidate must have a proven track record in the industry, strict attention to detail, high-quality customer service skills, and the ability to work well and collaborate in cross-functional teams.
- Led a team of scientists and engineers to enable the characterization, scale-up, and transfer of biological processes, including recombinant proteins (mammalian/microbial) and cell-based therapies.
- Maintain and streamline tech transfer processes, including Process Descriptions, Process Flow Diagrams, Bill of Materials, Batch Record writing, etc.
- Collaborate with PD and Manufacturing during development and scale-up activities.
- Provide routine project-related updates to internal teams and in Client-facing meetings.
- Support scale-up and manufacturing activities, including Scale-down model qualification, FMEA, deviation, and CAPA resolution with SMEs and Quality teams.
- Support Quality Assurance by assisting in employee training, document control, validation support, calibration, preventative maintenance support, change control deviation reporting, CAPA, risk analysis, etc. manufacturing responsibilities for clinical and commercial manufacturing programs.
- Assist in the preparation of Regulatory supporting documents, including CMC and Facilities sections.
- Collaborate with Facilities staff in maintaining equipment, including the calibration, preventative maintenance, and validation programs. Development and implementation of operation and maintenance protocols, including the execution and documentation of equipment validations as necessary.
- Manage relationships with outside vendors for equipment, consumables, and supporting services.
- Communicate and adhere to safety policies and goals.
- Maintain client and company confidentiality.
Knowledge & Skills
- Expertise in the scale-up of Upstream and Downstream processes
- Experience in the manufacturing processes from both mammalian and microbial systems including:
- Protein therapeutics: mAbs, bispecifics, therapeutic enzymes, vaccines
- Upstream: development and scale-up of Microbial and Mammalian (suspension and adherent) processes
- Cell therapy: stem/progenitor cells, iPSC differentiation, vaccines, exosomes
- Recovery: depth filtration, centrifugation (continuous), microfiltration, etc.
- Downstream: Chromatography (affinity, IEX, HIC, MM), TFF/NFF, precipitation/flocculation, column packing and evaluation
- Product formulation/stabilization
- Experience in biologics analytical characterization is highly desirable.
- Analytical mindset, both interpersonal and issue-related; good judgment and ethics; professional presence and demeanor
- Ability to continuously learn new techniques and skills and apply them to personal career growth.
- Outstanding interpersonal skills: ability to build strong relationships with cross-functional team members and lead through influence.
- Excellent verbal and written communication skills; strong presentation skills as this role requires the ability to communicate and connect with all levels of the organization.
- Must possess good to excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, PowerPoint, and Project.
- Working knowledge of Statistical and Engineering software applications (JMP, Mintab, Matlab, Visio, SuperPro Designer, etc.) is highly desirable.
- Must obtain a working knowledge of current global regulatory requirements and guidelines and perform within all Standard Operating Procedures (SOPs) and policies.
- Must maintain a working knowledge of commercial cGMP’s and phase-appropriate cGMP’s
- Ability to take responsibility and “get the job done” attitude in a high-energy, high-intensity, results-oriented environment.
Education & Experience
- Requires an MS or PhD degree from an accredited college or university with major coursework in a Scientific or Engineering discipline.
- Requires 15+ years (MS) or 10+ years (PhD) of Biologics experience in either Process Development and/or MS&T role.
- Experience in the development, scale-up, and transfer of Biological processes.
- Strong working knowledge of cGMP principles and Quality Management Systems.
Physical Requirements and Working Environment
- Flexibility is required for working hours. Some weekend work may be needed and earlier or later start/finish times may also be required.
- The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and laboratory environments and automated equipment.
- While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, and the ability to adjust focus. The employee must have manual dexterity and manual ability to effectively use computer terminals.
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