Process Development Scientist

About BioCina

BioCina is a biologics contract development and manufacturing organization (CDMO) specializing in Process Development and cGMP manufacture of microbial-based therapeutics and plasmid DNA, from preclinical to commercial production. The site, approved by the FDA for commercial manufacturing in 2020, has 35+ years of microbial fermentation experience and over the past 15 years, has worked on over 50 different products and has partnered with more than 30 customers globally. 

We are seeking a qualified and experienced Process Development Scientist to join our Upstream and Cell Line Development Programs team. This role involves performing experimental operations to enable the Process Development team to achieve its objectives and complete the Process Development activities for the development of new biological products.

Responsibilities

• Work with Senior Scientists to design, plan, execute, and analyze Process Development experiments for cell line generation, upstream, midstream, and downstream unit operations including fermentation, homogenization, chromatography, tangential flow, and normal flow filtration.
• Develop and perform analytical methods to the level appropriate for the needs of different products at different phases of clinical development.
• With supervision, work to design experiments, collect, analyze, and interpret the information produced, and integrate that information with project timelines and deliverables.
• Perform root cause investigations to confirm the root cause of manufacturing deviations.
• Maintain the Process Development Laboratory in a state of EHS and Quality compliance.
• Process transfer to QC and Production teams and troubleshooting of problems that may arise.
• Authoring reports on Process Development studies and process validation.
• Authoring and updating standard operation procedures used in the laboratory and maintaining records of activities in the laboratory to GLP standards.

Qualifications

• Minimum a bachelor’s degree in biotechnology or pharmaceutical/chemical engineering or equivalent with a PhD. specialized research preferred.
• Minimum of 3 to 5 years of related experience in a pharmaceutical/biotech Process Development and manufacturing environment, ideally in a microbial fermentation area.
• Hands-on experience in molecular biology techniques used for recombinant cell line development is preferred.
• Familiarity with process modeling and simulation software, with the ability to develop analytical methods and perform analytical testing.
• Hands-on experience in lab-scale fermentation, cell lysis, and purification techniques including chromatography, and filtration.
• Proficiency in statistical analysis and design of experiments (DoE) for process optimization and validation.
• Experience in process characterization, optimization, and scale-up activities, including troubleshooting and resolving technical issues that arise during Process Development.
• Ability to work collaboratively with teams and cross-functional stakeholders to identify and resolve technical challenges.
• Excellent written and verbal communication skills to present research findings, reports, and protocols.
• Attention to detail and the ability to learn new techniques.

Why work with BioCina?

• Competitive remuneration and benefits:  We offer a competitive salary, a comprehensive benefits package, and recognition for exceptional performance.
• Career growth opportunities:  We believe in growing our people and providing ample opportunities for career development and advancement.
• Innovation and impact:  Be part of a company that goes beyond the boundaries of science and makes a positive impact on patients’ lives.
• State-of-the-art facility:  Utilise cutting-edge technology and work in a modern, well-equipped facility that fosters creativity and productivity.
• Collaborative environment:  Work alongside passionate and expert professionals who are dedicated to excellence and share a common goal.

Join our team and help shape the future of biopharmaceuticals.  Together, we can make a difference.

To apply, please submit your resume and a cover letter outlining your qualifications, relevant experience, and why you are the right fit for this role. We thank all applicants for their interest, but only shortlisted candidates will be contacted.

As part of our commitment to creating a diverse and inclusive workplace, BioCina is an equal opportunity employer and seeks to have a diverse candidate shortlisted for this vacancy. All experienced candidates from a range of backgrounds, including genders, people with disabilities, and indigenous and ethnically diverse candidates are encouraged to apply.