Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems.
Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based
Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.
Company: Bionova Scientific LLCJob Description: Company Summary: Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients' expectations,
we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team.
Position Summary: The Senior Manufacturing Associate will actively contribute to the manufacturing projects at the Bionova Scientific West Warren site. As part of the Aseptic Operations Manufacturing group, you will have opportunities to work on and take ownership of a wide-ranging set of projects for troubleshooting and investigations, system and workflow implementation, facility buildout, and tech transfers of processes into a GMP multi-product manufacturing facility. The role will provide hands-on execution of complex experiments in a team setting.
The role will support GMP readiness and manufacturing activities. The scope of responsibilities may include but are not limited to Document writing (SOPs, Equipment URSs, etc. ), equipment validation execution support and single-use assembly design. Essential Duties and Responsibilities: Executes complex unit operations including but not limited to cell culture thaw, expansion, generation and maintenance of Master and Working Cell Banks, End of production banking, and drug product filling. Performs internal support activities such as maintenance of analytical and product filling equipment, stocking of consumables, discarding expired reagents, material coordination and weigh and dispense.
Maintains own training within compliance and trains other GMP associates upon completion of trainer qualification. Support in equipment troubleshooting, pilot scale material generation, non-GMP tox material generation and GMP Upstream, GMP Dowstream, and Bulk Fill activities. Author/review/approve technical documents such as tech transfer protocols and reports, experimental plans, production batch records, training materials, manufacturing SOPs, and regulatory filing documents per project needs.
Documents work according to c GMP and c GDP. Adheres to established regulations and follows c GMP established by site. Maintain cleanroom standards, practices, and housekeeping according to SOPs. Recognize any minor issues from the equipment and any affiliated documentation and take appropriate corrective action within scope. Notify leads/managers of issues and discrepancies immediately. backss impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones. Evaluate new technologies and innovations to improve operational efficiency or expand cell culture capabilities.
Contributes to quality activities such as investigations and area walk-throughs and support authoring deviations, CAPA, change control. MSAT support, Material receipt, and inventory organization. Other duties as assigned to ensure appropriate compounding practices Working Conditions: This position is required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.
Qualifications BS in Engineering, Life Sciences, or related discipline with 2+ years of relevant experience; AA degree with combination of industry experience and relevant degree; or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role. Must have aseptic technique experience. Basic Upstream and/or Downstream experience is a plus Cell Banking experience is a plus. Working knowledge of c GMP compliance as it pertains to procedures, processes, and manufacturing Creative thinker that can identify better and more efficient methods to address issues and gaps.
Demonstrate ability to work independently and on cross-functional teams. Ability to handle more than one task at a time, while maintaining attention to detail and working in a fast-paced environment. Strong analytical skills and attention to detail. Flexible mindset for a dynamic environment. Flexibility with work hours to meet business needs, including weekends and holidays, as needed. Compensation Range: The base compensation range for this role is between $32-40 an hour. However, the actual compensation may vary depending on your experience and qualifications. Bionova offered Benefits and Program Healthcare, Dental, and Vision insurance: Bionova offers health benefits at a subsidized rate.
Life Insurance and Disability Program: Life insurance is offered at 2x of annual base pay. Life insurance benefits start from the first day of employment. Disability programs are 100% covered by Bionova; a waiting period may apply as per company policy. Retirement Plan (401K) up to 8% employer match: 3% safe harbor contribution towards an employee's retirement plan and matches up to 5% dollar-for-dollar of base pay. Paid time off Holiday: As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.
early R&D projects with the goal of bringing real change to People with Diabetes and Obesity. Such projects include applying data science when developing advanced medical devices and digital decision support solutions. At NNRCSI, your skills, dedication and ambition will help us change lives for the better.
In exchange, we’ll offer you an opportunity to work with extraordinary talent, continuously learn and develop, and drive change to defeat diabetes and other serious chronic conditions. The team is comprised of collaborative, diverse and passionate people who have a true sense of pride in their work and are committed to helping others grow and develop their careers. You’ll also have
a platform to engage with key stakeholders on a global scale throughout the entire pipeline process. And while changing the future of diabetes and obesity treatment is no easy task, we also recognize the importance of an enjoyable workplace, which is why we’ve cultivated a culture of fun, ingenuity and innovation.
And our competitive compensation package and support of a healthy work-life balance all add to a best-in-class employee experience. We are changing lives for a living. Are you ready to make a difference? The Position The Scientist I will provide major contributions to the advancement of stem cell-based therapies to the clinic. This will be achieved by independently designing
and executing experiments, coordinating with cross-functional teams, and ensuring completion of project key deliverables.
The Scientist I will represent the organization to the external scientific community through presentations, and through active participation in external collaborations. RELATIONSHIPS Reports to a member of the Stem Cell CMC and Manufacture management team. Internal stakeholders include employees in Research and CMC in Novo Nordisk Headquarters in Denmark; employees in Manufacturing, Quality Assurance, Quality Control and Combination Product Development at Novo Nordisk Fremont. Individual will interact with external collaborators both academia- & industry-based.
Individual Contributor: does not manage other employees or contingent workers. ESSENTIAL FUNCTIONS • Major contributor to development projects (process- or analytics-related) through hands-on independent work of highly complex tasks involving multiple experimental activities and groups. Handles most situations independently, receives minimal guidance, but will seek advice and guidance on more complex issues. Can organize and manage complex projects and timelines. • Demonstrates a breadth of knowledge and skills to support the development, optimization, and management of protocols of high complexity to advance efforts with limited supervisor input.
Demonstrates deep understanding of subject matter (regarding specific technology & its use; specific biology; etc. ) and may occasionally demonstrate subject matter expertise. • Analyzes complex data with high degree of sophistication, connecting disparate datasets to reach conclusions and set direction on experiments. Contributes strong scientific acumen to enable projects and work towards a GMP manufacturing-friendly process and/or a QC assay transfer. Authors internal reports with limited guidance from supervisor.
• Effectively communicates and collaborates across global sites and guides project strategy by providing expert input to cross-functional project teams. Expected to represent the organization at external conferences and global meetings. Proposes, participates in, and may lead external collaborations. Can engage scientifically in an academic setting. • Maintains a strong understanding of theoretical knowledge and a connection to the external scientific community through continuous evaluation of relevant literature. Identifies, evaluates and implements new technologies that add value. • Leads cross-functional experimental teams to achieve project goals, mentor junior staff, and provide training.
May mentor or indirectly supervise less experienced team members. • Influences the pipeline by recommending, presenting, and championing new methodologies. • Demonstrated ability to identify technology-focused gaps and questions, and to propose solutions for long-term benefit of department, site, or company. • Works with Department Heads and Scientists to ensure better practice sharing and implementation within the team. • Achieves business goals, shares learnings, knowledge, skills, and promotes cross-functional teamwork.
• Develops superior cross-cultural understanding to effectively interact with relevant stakeholders in the global organization. QUALIFICATIONS • 12+ years’ relevant experience required, or a Master’s degree with 8+ years’ relevant experience, or a Doctoral degree with 2+ years’ post-doctoral and/or industry relevant experience can be considered. • Relevant required experience includes: o Track record of organizing and performing experiments of moderate complexity and performing at a high level of independence. o Demonstrates excellent verbal and written communication skills o Computer proficiency and the ability and desire to learn new software programs.
o Experience with aseptic technique and mammalian cell culture. Pluripotent stem cell experience strongly preferred. o Demonstrates project management knowledge, as well as strong organizational and time-management skills. • Preferred experience includes: experience in cell-based therapy technology or analytical method transfer; experience with gene editing of mammalian cells We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world.
We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, interaction, gender identity, interactionual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at -xyz X. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
