Scorpion Biological Services 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 Head of Process and Analytical Development, this person will provide scientific and engineering expertise for the Scorpion Biological Services Biomanufacturing Process Development group. This entails independently managing all day-to-day process development activities in conjunction with customers to enable cGMP production of pre-clinical and clinical-grade biologics, including therapeutic proteins, cell-based therapies and plasmid and viral vectors. Strict attention to detail, exceptional customer service skills and the ability to instill these qualities onto others on the team.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Develop and optimize upstream and downstream production processes that follow FDA and/or appropriate global regulations and guidelines.
- Independently lead and contribute to technology transfer from external client teams. Responsible for collaborating with cGMP operations group to modify existing “R&D” manufacturing processes and develop 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 developing and managing 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.
- Represent the Scorpion Biological Services biomanufacturing capabilities to outside customers and be able to respond to their questions independently and accurately.
- Leverage broad experience to train and supervise junior staff, as applicable
EDUCATION AND EXPERIENCE
- Requires a BS/MS/PhD Degree from an accredited college or university with major course work in a Scientific or Engineering discipline.
- Requires 5+ years (PhD), 10+ years (MS), 15+ years (BS) of Biologics process development experience.
- 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 essential.
- Knowledge of manufacturing processes in both mammalian and microbial systems is highly desirable.
- Perform scale down/scale up activities as appropriate to develop robust cGMP compliant processes.
- Experience in biologics analytical characterization is highly desirable.
- Analytical ability, both interpersonal and issue-related; good judgment and ethics; professional presence and demeanor.
- 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 Scorpion 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.
CERTIFICATIONS, LICENSES, REGISTRATIONS
- Process Excellence/Six Sigma green belt and/or black belt certification is highly desirable.
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. Will work extended hours during peak periods. May be required to work any time of the day, evening or night during the week or weekend.
- Will sit, stand, walk, and bend during working hours.
- Requires ability to reach, lift and carry up to 20 lbs.
- Requires manual and finger dexterity and eye‐hand coordination.
- Requires normal or corrected vision and hearing corrected to a normal range.
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