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发帖数: 180 | 1 我朋友正在帮国内厂家物色有领导能力的，有创业精神的专家，在国内药厂组建蛋白质
药物开发部。
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 [email protected] 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#8482;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#8482;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#8482;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. |
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