Senior Bioprocess Specialist
Senior Bioprocess Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
Overview
We are seeking a Senior Bioprocess Specialist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring Maryland. PBF is a oneofakind cGMPcompliant pharmaceutical manufacturing facility engaged in nextgeneration development for cuttingedge companies and government agencies. The professionals at PBF are engaging in trailblazing endeavors every day. Most exciting the end products vary so every year brings multiple opportunities for professional enrichment in original projects.
CAMRIS International LLC is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through highquality costeffective programs and research management services. We combine our proven systems with todays most effective evidencebased best practices. Our core practice areas include vaccine research development and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs.
Our employees enjoy a diverse collegial environment where individual contributions matter at all levels. At CAMRIS you will notably improve the lives of people at home and abroad.
Responsibilities
- Author standard operating procedures and record revisions.
- Draft deviations CAPAs change controls and lead investigations ensuring they are closed before deadlines.
- Be responsible for cGMP equipment implementation operation maintenance and training as assigned by the area manager.
- Cell expansion of microbial and mammalian cells from vial thaw to shake flasks fermentors/bioreactors and harvest using continuous centrifugation.
- Review and confirm cGMP using good documentation practices and in compliance with Quality Assurance compliance and good documentation practices for manufacturing documents procedures and records.
- Spotclean the cGMP manufacturing area leverage the aseptic technique and use gradeappropriate personal protective equipment as required to maintain cGMP spaces within environmental monitoring compliance specifications.
- Communicate effectively and consistently with other departments.
- Manage cGMP project inventory and kanban inventory per site policies and procedures.
- Prepare media buffers singleuse assemblies and components as required.
- Process onfloor offline sampling using cGMP analytical equipment and materials.
- Generate manufacturing deepdives process summaries run reports and quality documentation as required by site policies and procedures.
- Execute cell expansion of seeds and viral seeds as required.
- Manage and maintain manufacturingowned controlled temperature units (CTUs) and incubators per site policies and procedures.
- Perform bioreactor setup operation maintenance and cleaning per site policies and procedures.
- Prepare harvest equipment per SOP and batch record instructions per site policies and procedures.
- Execute cell lysis through chemical or physical (e.g. microfluidizer) cell disruption
- Perform recovery midstream unit operations including but not limited to depth filtration centrifugation and tangential flow filtration as required and per site policies and procedures.
- Pour resin pack columns verify HETP and Asymmetry and equilibrate columns.
- Develop purification batch records and AKTA UNICORN methods as required.
- Analyze UNICORN and other downstream result files attach per GDP to records summarize data and incorporate analysis into run reports as required.
- Sanitize empty and store columns per site policies and procedures.
- Responsible for training other personnel on procedures and operations of equipment.
- Ensure that all data is entered in records to be maintained on file for each product.
- Maintain a safe workplace ensuring awareness and observance of appropriate. safety and occupational health rules and regulations. The employee is required to attend safety training relative to their position and report any infractions of safety procedures to the facility Safety Officer.
- Perform light duties and other related duties as required and assigned including working in other sections.
- Function as tech transfer lead on two or more projects.
Qualifications
- A BA/BS degree in science (preferably chemistry biochemistry biology microbiology or engineering) and 10 years experience in a regulated laboratory environment or an equivalent combination of credentials and experience.
- Professional knowledge of the principles and practices applicable to the purification and downstream processing of materials for vaccines destined for earlyphase clinical trials.
- Extensive experience in the operation of cell disruption equipment centrifuges chromatography systems and ultrafiltration.
- Experience with at least one of the following (aseptic technique bioreactor operation BioCommand SCADA Software KrosFlo KMPi Tangential Flow Filtration (TFF) Systems AKTA UNICORN method development column packing and singleuse systems.
- Experience with supportive equipment such as validated washers depyrogenation ovens and autoclaves is preferred.
- Fillfinish and lyophilization experience is a plus.
- Strong interpersonal and communication skills (written and verbal).
- Must be currently eligible to work in the United States without visa sponsorship and have lived in the United States for three of the past five years if a nonUS citizen.
- A REAL ID or a U.S. passport is required to get on base at WRAIR.
CAMRIS offers a comprehensive benefits package including medical dental and vision insurance for individuals and families FSAs HSA life and AD&D insurance short and longterm disability legal services voluntary hospital indemnity critical illness and accident insurances EAP pet insurance 401(k) with employer match and Roth option tuition and professional reimbursement public transportation support in the DMV area a referral bonus program vacation with tenurebased increases PTO 11 paid holidays paid bonding leave and paid supplemental shortterm disability.
Employment is contingent upon successful completion of a Public Trustlevel background check a requirement for this position under an active federal contract. The background check process may include but is not limited to the following: 1 contacting your professional references; 2 verification of previous employment education and credentials; 3 a criminal background check; 4 use/abuse of federallycontrolled substances; and 5 a department of motor vehicle check. Candidates must be prepared to fullycomplete any required background check questionnaire during initial onboarding.
Required Experience:
Senior IC
Employment Type
Full-Time
