MSAT Associate II
San Diego, CA
Manufacturing – MSAT /
Full Time /
On-site
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The MSAT (Manufacturing Science and Technology) Department at Abzena provides technical leadership and supports technology transfer activities from Process Development to GMP Manufacturing. MSAT also plays a role in multiple secondary functions, in support of Quality Systems, Process Improvements, Production Equipment Implementation, Process Automation, Data Management, etc. The MSAT Associate is an individual who will be acting as Technical Support for either Upstream or Downstream Biopharmaceutical manufacturing. The Associate will be responsible for and adhere to the following:
Responsibilities
- Adhere to all GDP and cGMP requirements as required while fulfilling duties, responsibilities, and tasks.
- Provide technical support for active GMP production for their assigned unit operation(s) and to explain and present scientific information and data in support of this.
- Support and analyze risk assessments and facility fit for process transfer, scale up, and new material introduction.
- Support, or lead under supervision, Technology Transfer into cGMP Manufacturing from internal or external process development teams for assigned unit operation.
- Create Master Batch Records, Bill of Materials, Material Specifications, SOPs, Tech Transfer Documents, PFDs, and P&IDs in support of assigned unit operation.
- Subject Matter Expert of at least one unit operation in Upstream or Downstream Production, and journeyman experience in multiple unit operations.
- Write, revise, review, and otherwise support the document life cycle for Quality, Development, or GMP documentation.
- Support manufacturing deviations and implement assigned CAPA actions.
- Provide in-person and real-time GMP production support required for project success.
- Identify and support continuous improvement initiatives for the site and department.
- Required to cross-train on various tasks in other technical areas to support technology transfer activities.
- Develop working knowledge of cGMP raw materials, consumables, assemblies, in-process materials, designs, and part numbers to complete detailed cGMP records.
- Demonstrates technical proficiency, scientific creativity, and collaboration with others.
- Routinely collaborate with other internal departments and provide direct support, as needed.
- Note: This position summary is not intended to be all-inclusive. Employee may perform other related duties as directed to meet the ongoing needs of the organization
Qualifications
- BA/BS degree in chemistry, biology, chemical engineering or related field or comparable experience in industry.
- Minimum 3 to 4 years of experience with a BA/BS degree or 7+ years of experience with a high school diploma in a pilot-scale or GMP manufacturing role in the pharmaceutical or biotech industry.
- With a BA/BS degree, equivalent years of experience in an academic laboratory is acceptable if work included experience in Upstream or Downstream categories listed below.
- Knowledge and understanding of cGMPs and how they apply to duties and responsibilities.
- Knowledge and skill with aseptic technique required: BSC Operations and aseptic processing, including welding/sealing and/or single use sterile connectors
- Knowledge of cleanroom operations and proper gowning techniques
- Mammalian cell culture processes. Experience with CHO, Hybridoma, HEK, or other non/semi-adherent cell lines preferred
- Working knowledge of cell bank generation, maintenance, initial thaw and analysis (e.g., viability and viable cell density)
- Working knowledge of cell passaging and expansion
- Working knowledge of Single-Use Bioreactor Systems, such as: Wave/Rocker and Fed-Batch
- Media and/or Solution Preparation: acid/base conjugates, buffer titration, and formulation analysis techniques (e.g., pH, conductivity, osmolarity)
- Strong understanding of Microsoft Office Suite: Word, Excel, PowerPoint, Outlook, Teams, etc.
- Basic functions and graphing within Microsoft Excel required
- Familiarity with semi/fully automated manufacturing equipment preferred
- Familiarity with SCADA systems preferred
- Understanding of USP, 21 CFR, and ICH guidelines preferred
Physical Requirements
- Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
- Frequently lift and or move objects up to 30 pounds.
- Stand/walk during entire length of shift.
- Use arms, hands and fingers to handle, feel or reach.
- Ability to climb, balance, stoop, kneel, crouch, or crawl.
- Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.
- Ability to gown into ISO 7/8 suites and adhere to gowning policies and procedures.
- Work requires occasional days of more than the standard eight-hour shift, and weekend duty.
- Ability to type relatively quickly and work at a computer.
$60,000 - $85,000 a year
FLSA: Non-Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
