ReciBioPharm, the biologics business unit of Recipharm AB, is a visionary contract development and manufacturing organization (CDMO) that partners with companies seeking to develop and manufacture complex biological drugs and innovative therapies. Our dedicated team, state-of-the-art facilities, and unparalleled resources are crucial for advancing products from development to commercial launch. Our vision is to be the trusted and innovative CDMO partner for advanced therapy pioneers, so that we can bring life-changing therapeutics to patients. We partner with our clients to make treatments that can benefit vast patient populations, working across many indications. ReciBioPharm’s mission is to change healthcare through our intrepid and daring team engaging with clients to develop, manufacture, and supply breakthrough therapies that transform lives.
JOB SUMMARY
This position reports to VP, Nucleic Acid Technology and play a key role to lead laboratory /experimental approaches for optimized upstream production of plasmids. He/she will lead the efforts to design, execute, and interpret critical experiments for the success of plasmid upstream process including cell bank development, the growth of E. coli cells in shake flasks and fermenters, scale-up and tech transfer. This role will also support downstream process development for plasmid purification and related analytical development for in-process monitor and final product release. The individual will work collaboratively in a cross-functional environment including analytics, process engineering, GMP manufacturing and Quality. The successful candidate has a big potential to grow as a leader in nucleic acid process science group.
ESSENTIAL JOB FUNCTION
- Serve as a scientific/laboratory leader to guide & mentor scientists and associates within plasmid process science team
- Serve as a Subject Matter Expert in plasmid upstream process to lead plasmid process development activities in a combination of customer related, and internal related projects. These may include technology transfer, technology establishment, scale up manufacturing, process optimization, platform development.
- Assist in plasmid downstream process development using related chromatography and filtration technologies.
- Design & execute complex and technically challenging experiments for trouble shooting and method development.
- Support leadership team to evaluate new technologies and lead internal/external technical collaborations.
- Evaluate functional strengths and identify developmental areas with the ability to focus on continuous improvement
- Represent plasmid process development in cross-functional team forums including GMP manufacturing/non-GMP manufacturing, interdepartmental meetings, etc.
- Lead presentation, publication and/or patenting of findings or is a major contributor to these processes.
Experience and Skills
- D. in biological sciences with 3+ years, or M.S. with 5+ years, or B.S. with 10+ years of direct experience in pharmaceutical industry.
- Experts with extensive hands-on experience in coli microbiology, fermentation, and plasmid production.
- Extensive hands-on experience in plasmid characterization and common molecular biology analytics.
- Deep knowledge in molecular biology, plasmid DNA cloning and sequencing techniques.
- Previous experience in plasmid production for RNA application is highly desired.
- Experience with statistical design of experiments (DOE) is a plus.
- Experience with commercial scale up, large-scale bio-manufacture and cGMP is a plus.
- Ability to independently design experiments, analyze complex data and interpret and present experimental results, required.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.
- The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
- The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
- Specific vision abilities required by this job include close vision, and ability to adjust focus.
- In the performance of the duties of this job the employee is not required to travel
- The employee will be required to communicate using telephone and e-mail.
Who We Are
ReciBioPharm hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE.
Here at ReciBioPharm, we embrace ALIVE – our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging. Are you ready to come ALIVE with a daring and intrepid team? Don’t wait another minute; Apply today!
MEDICAL REQUIREMENTS
- This position requires a criminal background check and drug screening.
- COVID19 Vaccine required to come on site; Individuals seeking an exemption from this requirement for medical or religious reasons should reach out to Human Resources for an accommodation.
Benefits
ReciBioPharm offers a very competitive benefits package including medical, dental, vision, prescription drug coverage, life and disability insurance, 401(k), and generous vacation and time off policies among other attractive benefits. We operate in a world class facility to attract the best and brightest talent to work collaboratively in our mission to bring novel therapies to the patients who need them most.
ReciBioPharm is an Equal Opportunity Employer.