Manager, Protein Process Development
As a Manager of the (Protein) Process Development team, the candidate will:
- Manage the Development and Operations of Twist Protein Production
- Interact with Customers to evaluate protein project feasibility
- Interact with Product Management, Automation, Twist BioPharma and other groups to develop the Twist Protein Product Line
- Collaborate with Biopharma R&D and Automation teams to develop scalable production workflows at low, medium and high volumes
- Model capacity and recommend high throughput workflow options and hiring plans based on forecasts
- Objectively analyze and interpret experimental data and proactively provide recommendations for the advancement of project goals
- Be the subject matter expert for protein expression and purification workflows at any scale
- Optimize existing assays, expression protocols, and purification protocols to boost yield and success with difficult to work with protein variants
- Identify operational thresholds for products using process capability data; understand and reduce sources of variability in processes
- Validate processes and create infrastructure for traceable production processes using SOPs, raw material specifications, and master batch records with Quality SMEs for GMP processes
- Work with Product Management to define new products
- Work with internal and external customers on protein production projects and evaluate customer designs for feasibility; evaluate opportunities for product line fit in line with strategic vision
- Manage, train and mentor production team members; promote effective teamwork in the lab
- Identify and resolve complex technical or operational issues (including customer incidents); lead technical investigations and risk assessments related with processes
- Identify opportunities for process improvements, test and implement operational efficiency improvements to reduce TAT or COGs
- Track Process KPIs
- Lead cross function projects including running recurring project status meetings, assigning owners and due dates, and following up on progress
- Stay current with scientific literature and apply relevant findings to the design and interpretation of protein expression experiments.
- Collaborate in a fast-paced environment across multiple functional areas in the US, Europe and Asia.
In order to be successful in this role, you will meet the following requirements:
- A PhD or Master’s degree in biology, biochemistry, immunology, biology or process engineering
- 6+ years experience in the biotech/pharmaceutical industry, preferably with production of diagnostic and/or therapeutic antibodies
- Broad scientific understanding of recombinant antibody production, including: cell culture, transient and stable expression, cloning, cell culture (mammalian, baculovirus/insect and microbial systems) and affinity chromatography, automated chromatography stations such as AKTA FPLCs, and other forms of purification.
- Experience with developing High Throughput automated or semi-automated protein production/expression workflows
- Proficiency in expression construct design is strongly preferred
- Experience in development of analytical test methods for characterization of proteins and enzymes including HPLC, enzyme kinetics, protein quantification, spectrophotometer, spectrofluorometer, SDS-PAGE
- A successful track record of developing and manufacturing protein based commercial products
- Demonstrated scientific leadership, mentoring and organizational skills with respect to both managing and mentoring direct reports as well as external collaborations and/or CROs
- Ability to efficiently manage and prioritize multiple projects and coordinate material and data transfers
- Proficient with timeline development and project tracking
- Extraordinary attention to detail; excellent organizational and record keeping skills
- Excellent interpersonal and people skills
- Strong communication skills and experience giving scientific presentations
- Proficiency with Microsoft Word, Excel and PowerPoint
- Solid knowledge of biologics upstream and downstream processes, cGMP principles, ICH, FDA and EU guidance documents, and quality systems.
- Assertive and proactive with excellent follow through
- Demonstrated ability to work successfully in a cross-functional and highly collaborative team environment, and to communicate clearly and effectively both verbally and in writing to a variety of audiences.
- Prior cGMP gene therapy and/or biologics manufacturing experience for clinical/commercial stage products is highly preferred.
- Familiar with PLM, ERP and MES management systems
About Twist Bioscience
Twist Bioscience synthesizes genes from scratch, known as “writing” DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA.
At Twist Bioscience, we work in service of people who are changing the world for the better. In fields such as health care, agriculture, industrial chemicals and data storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers.
Twist Bioscience Corporation is an Equal Opportunity Employer. Twist Bioscience Corporation provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law.