A leading China Pharma Company has immediate openings for the following four leadership positions in its Yantai, China and Singapore sites. Please send your resume to hr@accelasci.com if interested.
Title: Head, Upstream Process Development

Functional Description:
Lead, build and develop a high performance Upstream Process Development group engaged in mammalian cell culture development for commercial therapeutic proteins, including subclone/clone selection, basal/feed media optimization, cell line stability study, cell culture manufacturing process development and scale up.Manage the day to day functions of the Upstream Process Development group while working hands on with the projects as necessary. The successful candidate will play a key role in developing, characterizing, and implementing monoclonal antibody cell culture processes from laboratory to pilot scale. The successful candidate will apply engineering and biological expertise to collaboratively develop and optimize cell culture processes suitable for cGMP manufacturing, and will interact with the teams within BioProcess Development and Operations, as well as collaborate with members from Manufacturing, Quality Control and Quality Assurance. Also interact with third party venders which provide essential and enabling services worldwide. The successful candidate will also be responsible for new technology development and process optimization as it benefits A-Bio€™s current and future cell culture platforms.

General Duties and Responsibilities:

1. Plan day-to-day activities within the Upstream Process Development in developing upstream processes suitable for large-scale commercial production for multiple biologics from inoculum and seed preparations, bioreactor operations and product recovery steps.
2. Lead and direct the Upstream Process Development group to perform and deliver project milestones and objectives, including cell line stability, cell line screening/cloning, cell culture process development, material supply for Research & Development activities, technical support for Manufacturing and Quality.
3. Design, develop and implement cell culture processes for recombinant protein production from laboratory to pilot scale using mammalian cells.
4. Serve as a technical expert in cell culture process development within the organization and provide support to Manufacturing and development laboratory.
5. Work with Operations closely and assist in technology transfer to cGMP manufacturing sites, provide technical support and support troubleshooting of existing processes.
6. Work closely with internal groups to ensure that business objectives are met, especially cell line development group.
7. Serve as author/reviewer as required for relevant CMC sections for regulatory submissions.
8. Ensure that development reports are completed in a timely fashion for any development work that serves as the basis of manufacturing processes cited in regulatory submissions and/or transferred to partners/licensees.
9. Introduce novel technologies to improve process performance.
10. Interact with research institutes and experts in relevant fields to continuously improve group performance.
11. Lead IND (CMC Section) filing process.

Qualifications:

The ideal candidate will have a Ph.D. degree in relevant biological sciences and/or engineering, such as molecular biology, analytical and biochemistry, protein chemistry or biological engineering, biochemical engineering with minimum of 5 years industry experience in the pharmaceutical and/or biotechnology industries, or MS with at least 7 years of experience or BS/BA in life sciences with at least 10 years of laboratory experience in an industry setting.

Applicants are expected to exhibit strong leadership skills and have a proven ability in the cell line development in the biopharmaceutical industry. The candidate must have:

1. Knowledge and experience of the design, optimization and scale-up of cell culture processes is a necessity.
2. Knowledge of cell culture process development equipment and systems, and their maintenance.
3. Direct experience with mammalian cell culture process development and process transfer for clinical or commercial manufacturing of biopharmaceutical product(s) highly preferred.
4. Knowledge in the use of DOE to conduct experiments for media optimization, selection of process parameters and scale up conditions.
5. Hands-on experience with unit operations such as lab and pilot-scale bioreactor operation, centrifugation, clarification and filtration.
6. Process validation and cGMP experience is desirable.
7. Must be highly motivated, have excellent organizational and communication skills, and must be able to work independently and as part of a multi-disciplinary team.
8. Demonstrated accomplishments of successful mammalian cell culture process development and scale up for commercial protein therapeutics.

Title: Senior Scientist and Project Manager, Cell Line Development

Functional Description:
Lead, build and develop a high performance Cell Line Development group engaged in mammalian cell line development for commercial therapeutic proteins, including gene and vector construction, subclone/clone selection, third party vendors support and novel cell line platforms development.Manage the day to day functions of the Cell Line Development Group while working hands on with the projects as necessary. Responsible for directing staff on the timing, implementation and execution of project goals; training and developing staff, in all procedures and required documentation; providing strategic insights on novel cell line platforms; initiating the continuous improvement of the groups operations to improve efficiencies; reporting directly to senior management on progress of projects and issues; serving as the key leader interfacing with third party service providers; participating in evaluating business opportunities in a global business environment.

General Duties and Responsibilities:

1.    Oversee all aspects of the Cell Line Development Group including scheduling, staffing and project management, as well as executing tasks.
2.    Generation and characterization of stably transfected cell lines for the expression of multiple product candidates.
3.    Apply high-throughput methods to streamline cell line screening and cloning.
4.    Perform full genetic characterization of cell lines and target products generated by new cell lines.
5.    Lead and direct novel expression vector design and construction for commercial products.
6.    Prepare and review of technical reports and publications, including Cell Line Development project reports.
7.    Responsible for development and execution of procedures to enhance productivity and reduce timelines.
8.    Responsible for the reporting of Project progress to senior management and project management in a complex matrix environment.
9.    Oversee and execute the cell culture production of products made by created cell lines/clones.
10.    Oversee the identification, sourcing, installation and operation of new equipment to enhance productivities.
11.    Oversees non-GMP Cell line inventory including the storage and tracking of parental, packaging and production cell lines.
12.    Recruit talents globally to strengthen staffing the Cell Line Development Group.
13.    Support IND (CMC Section) filing.

Qualifications:

The ideal candidate will have a Ph.D. degree in relevant biological sciences and/or engineering, such as molecular biology, analytical and biochemistry, protein chemistry or biological engineering, biochemical engineering with minimum of 5 years industry experience in the pharmaceutical and/or biotechnology industries, or MS with at least 7 years of experience or BS/BA in life sciences with at least 10 years of laboratory experience in an industry setting.

Applicants are expected to exhibit strong leadership skills and have a proven ability in the cell line development in the biopharmaceutical industry. The candidate must have:

1.    Practical experience with mammalian cell culture techniques including sterile technique, passaging cells and transfecting cells.
2.    Practical experience and knowledge with molecular biology techniques including qPCR, plasmid construction and preparation.
3.    Relevant experience on the optimization of transfection, growth and selection conditions for a variety of mammalian cell lines, mainly CHO.
4.    Design strategy for multiple cell line platforms for advanced, novel therapeutic proteins including human cell lines (e.g. PER.C6, HEK293)
5.    Demonstrated leadership in managing teams and projects in a complex matrix environment.
6.    Must be organized, self-motivated and result-oriented.
7.    Has proven rack records of delivering milestones under time pressure and limited resources.
8.    Demonstrated creative complex problem solving, involving in-depth evaluation and analysis of variables.
9.    Independently develops methods, techniques and evaluation criteria to achieve results.
10.    Monoclonal antibody cell line development experience is a must.

Title: Head, Biologics Operations

Functional Description:
Our company is currently seeking a well recognized, highly motivated and experienced senior leader in biopharmaceutical industry to lead, build and manage a high performance biotech operations group to engage in early stage biologics development of recombinant protein therapeutics and monoclonal antibodies, from cell line to IND filing. This group is composed of Upstream Process (seed, cell culture and recovery), Downstream (protein purification) and Facility & Engineering. Multiple projects begin with tech transfer internally and/or externally, from cell banking and storage, cell culture process, media preparation, product recovery and purification, scale-up, non-GMP production of toxicology study material, tech transfer the bioprocess technology to commercial-scale production facilities, and so on. Additionally, this leader will support design and planning of biologics manufacturing plant for clinical study material and large scale commercial manufacturing, select qualified suppliers and service providers worldwide, support CMO projects, and manage cross-functional teams in a global business environment. Will collaborate with members from Process Development, Quality Control and Quality Assurance, Corporate Support functions.

General Duties and Responsibilities:

1.Recruit talents globally in biologics manufacturing to establish a high performance team to conduct process scale up and production of pre-clinical and clinical study material for multiple protein therapeutics, especially monoclonal antibodies, working closely with development from product selection, cell line construction to pre-clinical material production, tech transfer and IND filing.
2. Responsible for the entire cGMP production facility including daily operations, maintenance and repairs, schedule planning and execution, document management, utility system operations, warehouse operations, and so on.
3. Develop facility improvement and/or renovation plant and design, prepare capital requirement schedule and obtain approval of project proposal and execute plan flawlessly.
4. Develop and direct staff by active coaching and training while cultivating collaborative team culture, creative problem-solving and result-driven operations.
5.Lead the high performance team by setting clearly defined objectives and business goals, execute flawlessly to accomplish critical deliverables including upstream process and protein purification operations, selection of process and manufacturing technologies, in-process monitoring and analysis, large scale production, tech transfers and so on.
6. Communicate regularly to senior management, executives and board on progress of projects, business opportunities and related business matter via presentations and reports.
7. Manage and plan budget, projects, personnel and schedules to perform specific projects according to clinical timing and deliverables and overall business priorities.
8. Support strategic planning of product and process development to meet the organization€™s strategic goals and long term growth.
9. Lead technology transfer internally and externally, technical support of large scale non-GMP and support cGMP production and plant operations.
10. Interact regularly and communicate proactively with internal and external customers, to resolve process and operations issues promptly.
11. Build and establish appropriate processes and systems to effective improve operating productivity and manage continuous improvement programs.
12. Support business development in project evaluation, contract negotiation and provide leadership and technical inputs to potential projects.
13. Introduce and develop novel process technologies to advance process productivity and biologics manufacturing efficiency.
14. Apply innovative technical ability and knowledge to critically analyze the experimental results and literature findings.
15. Maintain well-organized, clear and complete records of collected data and process in a highly secure and confidentiality-protected work environment.
16. Contribute in preparing materials and sustaining data security that protect the intellectual property portfolio of the company and clients.
Qualifications:

The ideal candidate will have a B.S./M.S./Ph.D. degree in relevant biological sciences and/or engineering, such as biology, analytical and biochemistry, protein chemistry or biological engineering, biochemical engineering, mechanical engineering with minimum of 10 years relevant industry experience in the pharmaceutical and/or biotechnology industries. Applicants are expected to exhibit strong leadership skills and have a proven ability in the process development and production in the biopharmaceutical industry. The candidate must have:

1.    Excellent project team and matrix system management skills.
2.    Excellent communication, documentation and technical writing skills.
3.    Experience in biologics manufacturing, plant engineering and design, facility maintenance and repairs, productivity and efficiency improvement, production systems improvement for producing clinical and commercial biopharmaceuticals.
4.    Proven records and demonstrated ability in biologics manufacturing, process scale up, and productivity improvement.
5.    Significant successful experience in leading technical and operations departments involved in process scale up activities from laboratory to pilot and commercial scale manufacturing.
6.    Familiarity of regulatory issues pertaining to the manufacture of biologics, large scale biopharmaceutical unit operations and process validation.
7.    Appreciation and understanding of cGMP and practices.
8.    Demonstrated innovative problem-solving skills under resource constraints and time pressure.
9.    Ability to make decisions that require in depth evaluation of extremely complex factors, anticipation of unknowns, and interactions with multiple stakeholders.
10.    Proficient in computer and IT concerning application of process modeling and numerical analysis software such as Excel, Matlab, and/or SuperPro.
11.    Strong capital cost and operating cost knowledge and management in biologics production.
12.    Hands-on experience of monoclonal antibody development is highly desirable.

Title: VP/Senior Director, BioProcess Development & Operations

Functional Description:
Our company is currently seeking a well recognized, highly motivated and experienced senior leader in biopharmaceutical industry to lead, build and manage a high performance bioprocess development and biotech operations group to engage in early stage biologics development of recombinant protein therapeutics and monoclonal antibodies, from cell line to IND filing. This group is composed of Cell Line, Upstream Process (cell culture and recovery), Downstream (protein purification) and Analytical Development.Multiple projects begin with cell line design and construction for target proteins, followed by cell culture process development, media optimization via DOE, product recovery and purification, scale-up, non-GMP production of toxicology study material, tech transfer the bioprocess technology to commercial-scale production facilities. Additionally, this leader will support design and planning of biologics manufacturing plant for clinical study material and large scale commercial manufacturing, select qualified suppliers and service providers worldwide, support CMO projects, and manage cross-functional teams in a global business environment. Will collaborate with members from Manufacturing, Quality Control and Quality Assurance.

General Duties and Responsibilities:

1.    Recruit talents globally in bioprocess development and biologics manufacturing to establish a high performance team to conduct early stage protein therapeutics, especially monoclonal antibodies, development from product selection, cell line construction to per-clinical material production, tech transfer and IND filing.
2.    Develop and direct staff by active coaching and training while cultivating collaborative team culture, creative problem-solving and result-driven operations.
3.    Lead the high performance team by setting clearly defined objectives and business goals, execute flawlessly to accomplish critical deliverables including cell line development, selection of process technologies, cell culture process design and optimization, protein recovery and purification and in-process monitoring and analysis, large scale production issues, tech transfers and so on.
4.    Communicate regularly to senior management, executives and board on progress of projects, business opportunities and related business matter via presentations and reports.
5.    Manage and plan budget, projects, personnel and schedules to perform specific projects according to clinical timing and deliverables and overall business priorities.
6.    Support strategic planning of product and process development to meet the organization€™s strategic goals and long term growth.
7.    Lead technology transfer internally and externally, technical support of large scale non-GMP and support cGMP production and plant operations.
8.    Interact regularly and communicate proactively with internal and external customers, to resolve process and operations issues promptly.
9.    Build and establish appropriate processes and systems to effective improve operating productivity and manage continuous improvement programs.
10.    Support business development in project evaluation, contract negotiation and provide leadership and technical inputs to potential projects.
11.    Introduce and develop novel process technologies to advance process productivity and biologics manufacturing efficiency.
12.    Apply innovative technical ability and knowledge to critically analyze the experimental results and literature findings.
13.    Maintain well-organized, clear and complete records of collected data and process in a highly secure and confidentiality-protected work environment.
14.    Contribute in preparing materials and sustaining data security that protect the intellectual property portfolio of the company and clients.
15.    Interact with research institutions and academic scholars to collaborate on various advanced technical projects and aspects of scientific studies focusing on process and productivity improvement.
Qualifications:
The ideal candidate will have a Ph.D. degree in relevant biological sciences and/or engineering, such as molecular biology, analytical and biochemistry, protein chemistry or biological engineering, biochemical engineering with minimum of 15 years industry experience in the pharmaceutical and/or biotechnology industries. Applicants are expected to exhibit strong leadership skills and have a proven ability in the process development and production in the biopharmaceutical industry. The candidate must have:

1.    Excellent project team management and matrix system management skills.
2.    Excellent communication, documentation and technical writing skills.
3.    Experience in cell line development, cell culture, purification and analytical sciences for producing clinical and commercial biopharmaceuticals.
4.    Proven records and demonstrated ability in process development and productivity improvement.
5.    Significant successful experience in leading technical departments involved in process development and scale up activities from laboratory to pilot and commercial scale manufacturing.
6.    Familiarity of regulatory issues pertaining to the manufacture of biologics, large scale biopharmaceutical unit operations and process validation.
7.    Appreciation and understanding of cGMP and practices.
8.    Demonstrated innovative problem-solving skills under resource constraints and time pressure.
9.    Ability to make decisions that require in depth evaluation of extremely complex factors, anticipation of unknowns, and interactions with multiple stakeholders.
10.    Proficient in computer and IT concerning application of process modeling and numerical analysis software such as Excel, Matlab, and/or SuperPro.
11.    Strong capital cost and operating cost knowledge and management in biologics development.
12.    Hands-on experience of monoclonal antibody development is highly desirable.