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.
The Analytical Development associate will primarily be responsible for supporting analytical methodology evaluations and implementation (qualification) for use in routine QC testing. This highly motivated member of the AD Unit will support the organization through the execution of activities such as RNA characterization testing (i.e. integrity, content, polyA, capping efficiency), Microscopic and chromatographic characterization, molecular and chemistry method platform evaluations to support the assay transfer process to the QC lab for release testing. This AD team member will be responsible for initiating and assisting in qualification studies and technical writing activities while adhering to cGMP and GDP practices.
The Associate will assist in implementing the Analytical Development methodologies employed for RNA, Plasmid and Microbiome based platforms.
ESSENTIAL JOB FUNCTIONS
- Actively participates in fostering a positive, collaborative work culture.
- Authoring and revision of standard operating procedures, test methods, protocols, and reports.
- Participate in execution of method qualifications, technical transfers, release testing, and method validations.
- Testing of material utilizing methods such as CFU, TCC, VCC, % Viability, growth kinetics, qPCR, Karl Fischer, bacterial enumeration, bioburden, Integrity, % Encapsulation, UPLC etc.
- Data analysis and review.
- Perform equipment calibrations.
- Execute method and equipment troubleshooting and optimization, as needed.
- Maintain documentation in accordance with GDP.
Experience and Skills
- S. degree in science or a life science-related field of study.
- 2-4 years of experience in GMP environment.
- Proficiency in operation of microscopes, HPLCs, gel electrophoresis.
- Strong technical laboratory skills (e.g. pipetting, weighing, and measuring pH, equipment calibrations)
- Experience with writing standard operating procedures and qualification protocols and reports
- Familiarity with FDA, ICH, and EU Regulations and Guidelines
- Involvement in continuous improvement initiatives and laboratory investigations
- Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience desirable
- Bachelor’s degree in Bioscience with a minimum of 2 years of industry experience, or a Master’s degree with a minimum of 1 year of industry experience.
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!
- 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.
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.