Senior Manufacturing Associate, Drug Product
Arranta Bio is a rapidly growing and dynamic bio-pharmaceutical contract development and manufacturing organization (CDMO). Our vision is to be the best in class CDMO providing development and GMP manufacturing services to microbiome innovators within the pharmaceutical industry. Therapies focused on the human microbiome are exhibiting incredible potential towards revolutionizing disease etiology and associated medical treatments. Arranta Bio’s mission is to build a world class organization which provides microbiome bio-pharmaceutical innovators with a single source of supply from early process development through clinical and commercial GMP finished product.
WHO ARE WE
Arranta 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 Arranta Bio, we embrace ALIVE – our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging.
We embrace our challenges as opportunities.
We are empowered to think and act.
We never settle; we strive to improve through purposeful creativity.
We build aligned teams who learn, grow, and deliver.
We are committed to building strong relationships.
Are you ready to come ALIVE with a daring and intrepid team? Don’t wait another minute; Apply today!
The Senior Manufacturing Associate will lead in the daily operation of manufacturing equipment used in the production of Live Biotherapeutics (LBT) or enzymes, including the use of fermentation vessels, autoclave, centrifuge, and freeze dryer. Strict adherence to cGMP compliance will be required.
Although the focus of the Senior Manufacturing Associate will primarily be support of the fermentation operation, other duties will be shared as determined by the Head of Manufacturing.
The Senior Manufacturing Associate will also be responsible for training and oversight of junior manufacturing staff as required.
• Preparing for and execution of manufacturing batch records, work instructions and/or SOPs, focus on ‘right the first time’ executions.
• Maintain up to date training records.
• Documentation of all activities to meet cGMP requirements. Maintain GMP compliance in assigned work.
• Complete preventative maintenance task and work notifications on time.
• Ensure tasks are executed with a method of prioritization – interpret production schedules and complete tasks accordingly. Including shift exchanges, 1-1’s, meetings, email, etc.
• Participate in other required activities (perform safety inspections; participate in improvement projects, etc.).
• Follows Standard Operating Procedures (SOP’s)
• Maintains a high level of sterile awareness
• Operates equipment in a safe manner
• Uses chemicals (i.e. acids & bases) in a safe manner
• Performs preventive maintenance
• Support for occasional non-routine work hours
• Capable of lifting at least 50 lbs unassisted, or up to 100 lbs with the assistance of one other person
• Work in a cleanroom
• Adhere to cGMP guidelines
• Media preparation and loading
• Sterilization of fermentor media
• Bioreactor cleaning
• Bioreactor sampling
• Local and remote monitoring of bioreactors
• Vessel maintenance (valves, gaskets, o-rings, calibration, etc.)
• Rig hoses as necessary to harvest contents of bioreactors
• Attach pumps and set speeds based on separation efficiency
• Configure centrifuges for harvest
• Monitor spin conditions and optimize as necessary
• Maintain awareness of contamination sources
• Centrifuge cleaning and sanitizing with partial disassembly
• Slurry collection
• Slurry modifications (addition of recipe components)
Floor and Cryogenic Freezers
• Freezer start/stop
• Monitor temperature
• Pour slurry into trays for freezing
• Freezer defrost and cleaning
Lyophilizers (Freeze Dryers)
• Load/Unload freeze dryer
• Set process parameters
• Local and remote monitoring of freeze dryer performance
• Defrost condensers
• Harvest coarse power
• Load/Unload items to be sterilized
• Enter proper sterilization times
• Verify autoclave operating parameters and adjust as necessary
• Clean vessels thoroughly
• Clean, inspect, and test valve arrays
• Fill vessels with desired chemical (acid, base, anti-foam)
• Prepare tubing and valve arrays for attachment to vessel
• Sterilize addition vessels in autoclave
Experience and Skills
Education And/Or Experience
- High School, Technical Degree required
- B.S. in Biology, or related field preferred.
- 4+ years of manufacturing experience
- cGMP clean room experience required
- Experience with Deviation investigations and CAPA implementation preferred
- Working knowledge of Microsoft Outlook, Word and Excel required.
- Good laboratory skills and excellent record keeping, including GDP, is required.
- Ability to work independently and stay on task in a fast-paced environment without direct supervision.
- Ability to work well with others in a collaborative team environment.
- Regular and reliable performance and attendance required.
- Preferred experience with anaerobic culture techniques
- Basic PC skills (Microsoft Office)
- Able to work in a rapidly changing climate – reacts well to change
- Team player
- Ability to handle multiple tasks while remaining focused
- Reliable, dependable, and organized
- 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 20 pounds and occasionally lift and/or move up to 50 pounds.
- Specific vision abilities required by this job include close vision, and ability to adjust focus.
- No travel required.
- Communicate using telephone and e-mail.
- Phone reimbursement policy for qualified individuals
- Free parking
- Highly competitive healthcare with many plan options:
- Medical (HMO/PPO/EPO)
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Up to 10 weeks of 100% paid maternity leave
- 2 weeks of 100% paid paternity, domestic partner, & adoption leave
- Educational assistance program
- 401k (traditional and Roth offered) with 100% match on first 5% deferred.
- A suite of Arranta Bio paid insurance coverage, including life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- Employee Referral program
- Competitive PTO plan, in addition to 10 company paid holidays (includes 2 floating holidays)