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 methods 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.
The position is based in San Antonio, Texas and directly reports to the Sr. Director/Head of Process and Analytical Development. The candidate will provide scientific expertise for the Scorpius BioManufacturing Process Development group. This entails independently performing and/or managing day-to-day process development activities in conjunction with team members, project leaders and customers to enable cGMP production of pre-clinical and clinical-grade biologics, including therapeutic proteins, cell-based therapies and plasmid and viral vectors. The ideal candidate must have strict attention to detail and exceptional customer service skills.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Assist in the development and optimization of upstream and downstream production processes that follow FDA and/or appropriate global regulations and guidelines.
- Assist in technology transfer from external client teams. Responsible for collaborating with cGMP operations group to modify existing manufacturing processes and developing them for clinical-scale, cGMP-compliant manufacturing. This includes transfer of processes into the cleanroom environment, process troubleshooting and in collaboration with the Biomanufacturing Operations team, generation of all relevant cGMP documentation (Batch Records, Compounding Records, Operating Procedures, etc.).
- Collaborate with Facilities staff in maintaining the calibration, preventative maintenance and validation strategy for all Process Development equipment. This includes the development and implementation of operation and maintenance protocols for equipment and the execution and documentation of equipment validations as necessary.
- Assist in preparing CMC documents related to Process Development projects.
- Support Quality Assurance group by assisting in employee training, document control, validation support, calibration and preventative maintenance support, change control deviation reporting, CAPA, risk analysis, etc.
- Manage relationships with outside contractors including equipment and consumable vendors, calibration and service contracts and validation firms.
EDUCATION AND EXPERIENCE
- BS or MS Degree from an accredited college or university with major course work in a Scientific or Engineering discipline required.
- 5+ years (BS) or 2+ years (MS) of Biologics process development experience required.
- Strong working knowledge of cGMP principles and Quality Management Systems.
- Experience working in a cGMP clinical and/or commercial-scale manufacturing environment is highly desirable.
- Knowledge of both upstream and downstream biomanufacturing processes is preferred.
- Experience with day-to-day biologics laboratory techniques.
- Knowledge of manufacturing processes in both mammalian and microbial systems is desirable, such as:
- Aseptic processing
- Cell therapy: stem/progenitor cells, iPSC differentiation, vaccines, exosomes
- Protein therapeutics: mAbs, bispecific proteins, therapeutic enzymes, vaccines
- Microbial fermentation – scale-up
- Mammalian cell culture: suspension & adherent – scale-up
- Product recovery: filtration, centrifugation, microfiltration, etc.
- Protein purification: UF/DF, ion exchange, Protein A/G, HTP, HIC
- Product formulation / stabilization
- Experience in biologics analytical characterization is highly desirable.
- Analytical ability, 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.
- Must maintain a working knowledge of phase-appropriate cGMPs as they apply to various phases of product clinical development.
- Must obtain a working knowledge of current global regulatory requirements and guidelines and perform within all Scorpius Biological Services Standard Operating Procedures (SOPs) and policies.
- Ability to take responsibility and “get the job done” in a high-energy, high-intensity, results-oriented environment.
- 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, Power Point, and Project.
- Working knowledge of Engineering software applications (Visio, SuperPro Designer, Matlab, Minitab, etc.) highly desirable.
Physical requirements and working ENVIRONMENT
- This position will work in a well‐lighted air conditioned and heated laboratory/department. May be exposed to electrical, mechanical and chemical hazards and other conditions common to a laboratory environment. May be exposed to pathogens and other conditions common to a clinical laboratory environment. May have bodily exposure to refrigerator/freezer temperature, especially hands and face.
- 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 ability to adjust focus. The employee must have the manual dexterity and manual ability to effectively use computers.
- Flexibility is required. Some weekend work may be needed and earlier or later start & finish times may also be required.
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