Current Job Postings

Qualification and Experience:

BS/MS in Life Science, Engineering or equivalent. 0-4 years of experience; must have demonstrated ability to design and evaluate experiments; must utilize statistical design of experiments and be flexible in executing and responding to changes in scheduling, along with innovating solutions in a transparent team environment; must have strong focus on creativity and continuous improvement.

Job Responsibilities:

This position will initially report to the Head of Upstream Development with responsibilities including but not limited to:

  Process Development(40%)

• Plan and execute experiments performed to evaluate cell lines/strains, culture media, feeding strategies and process conditions.
• Work in collaboration with Operations group to execute protocols, experimental plans, and critical production batches.
• Represent functional area in team meetings as required.
• Author experimental plans, reports, and operating procedures.
• Maintain a current laboratory notebook with scientific rigor to meet project needs for process development.
• Implement state of the art science and technology with respect to media development, cell line development, primary recovery, and bioreactor systems while exploiting miniaturization to the extent possible.
• Collaborate with other function to deliver an efficient low cost solution to customers.
• Develop effective mammalian/fermentation scale-down capabilities and implement effective and scalable process control strategies.
• Media design and optimization for mammalian cell culture and microbial fermentation process development at various scales.

   Equipment and Facilities (30%)

• Participate in design and start-up of facility and process equipment. Partner with vendors to deliver state of the art technologies.
• Innovate technologies that enable the miniaturization of development systems and increase the efficiency of process development
• Develop efficient and innovative solutions to enable multi-host development and cGMP facility design and operation.
• Follow full GMP guidance and fulfill all Quality Assurance requirements where required.
• Operate safely and according to company environmental requirements.

  Culture (20%)

• Evaluate technologies and propose ideas for innovation.
• Support business development activities as required.
• Present data or ideas in team meetings.
• Follow all company best practices to minimize cost and meet budgetary requirements.
• Head of Process Development & Manufacturing may assign other responsibilities as required.

Qualification & Experience:

PhD or MS in Biochemistry/Biotechnology or related subject area.  Minimum 5 years of experience with a proven track record in QC of protein therapeutics.  Strong leadership skills in directing a highly trained scientific team to meet ONS objectives.

Job Description:

This position will directly report to the VP of Development Sciences with the responsibilities including (but not limited to):

Lead QC group in qualification and validation of analytical methods for clinical protein therapeutics (50%)

• Establish a talented functional group of 3-5 or more staff.
• Setup lab & equipment to establish the labs.
• Oversee the transfer and qualification of methods; guide stage-appropriate method validation with hands on experience. 
• Work closely with Analytical and Formulation Sciences to ensure successful implementation of developed methods.  Guide the group to focus on established and new art science and technology to meet project needs.
• Publish and patent scientific work and present work in leading international conferences.

Support Quality functions in GMP manufacturing (40%)

• Provide infrastructure for quality testing of in-process, lot release, and stability testing for Oncobiologics clinical manufacturing projects.
• Address QC/GMP issues of biologic products. Work closely and support Analytical, Formulation and Process Development on QC/GMP issues, including OOS results and NC/CAPA resolution.
• Evaluate CRO/CMO labs; coordinate and manage the outsourcing of specific methods, including those for environmental monitoring and raw materials testing

Culture (10%)

• Support business development activities as required.
• Support solutions for innovation and collaboration.
• Develop customer relationships with peers.

Qualifications:  PhD/MS/BS in Biochemistry, Chemistry, Chemical Engineering or equivalent

Experience:Minimum 5+ years of experience in absence of graduate degree, 2+ years if MS, or entry level PhD; must have demonstrated ability to design and evaluate experiments; must utilize statistical design of experiments and be flexible in executing and responding to changes in scheduling, along with innovating solutions in a transparent team environment; must have strong focus on creativity and continuous improvement. Strong knowledge of both preparative and analytical chromatography required.

Job Description:

This position will report to the Head of Purification Development with the responsibilities including (but not limited to):

A.     Purification Development (50%)

• Represent purification development in team meetings as required.
• Develop purification platform process and associated analytical in-process analytical through the application of design of experiment for rapid speed to First in Human Studies.
• Implement state of the art science and technology for screening chromatography resins and other separation techniques including automated liquid handling systems.
• Collaborate with other functions to deliver an efficient low cost solution to customers.
• Execute and design experiments while maintaining a current laboratory notebook with scientific rigor to meet project needs for process development.
• Evaluate Protein-A, Ion Exchange, Hydrophobic Interaction chromatography resins and other separation techniques for rapid process development and protein separation modeling.
• Develop scalable chromatography methods that minimize types of buffers and maximize efficiency of operations in manufacturing.
• Have core competency in filtration including methods for cell culture/fermentation clarification, tangential flow filtration and viral clearance.
• Execute process development enabling analytics required to make development decisions rapidly.  Should have experience with HPLC/UPLC, electrophoretic, ELISA and SPR technologies and equipment.

B.     Equipment and Facilities (30%)

• Participate in starting up facility and process equipment.  Work to deliver state of the art technologies specifically around liquid handling systems for high-throughput process development.
• Develop efficient and innovative solutions to enable multi-host development and cGMP facility design and operation.
• Follow full GMP guidance and fulfill all regulatory requirements where necessary.
• Operate safely and according to company environmental requirements.

C.     Culture (20%)

• Evaluate technologies and propose ideas for innovation.
• Support business development activities as required.
• Present data or ideas in team meetings.
• Follow all company best practices to minimize cost and meet budgetary requirements.
• Head of Purification Development may assign other responsibilities as required.

Qualification and Experience:

• BS/MS in Biochemistry/Biotechnology/Chemical Engineering or related field with 2 years of industry experience in protein biotherapeutics. PhD candidates will not be considered.
• Experience with antibody/protein engineering techniques  such as library screening (phage/yeast or in vitro display methods) and protein design is required
• Experience with characterization of engineered proteins/antibodies using ELISA/Forte Bio-Octet /Biacore
• Ability to multi-task and manage multiple projects at the same time
• Motivation to be part of a high performance, diverse, and efficient scientific team.
• Excellent spoken and written communication skills.

Job Responsibilities:

   Phage Display, Selection and Characterization (90%)

• Perform library screening and construction in scFv/Fab format. Library screening using phage/yeast display is required
• Strong experience in characterization of biologics using various biophysical techniques particularly Octet and Biacore
• Structural or computational protein engineering experience with a sound knowledge of antibody structure and function
• Knowledge of cell based assay development is desired
• Focus on established and new-art science and technology to meet project needs for analytical sciences.
• Support publication and patenting of scientific work.

  Culture (10%)

• Support business development activities as required.
• Support solutions for innovation and collaboration.
• Develop customer relationships with peers.

Qualification and Experience:

Ph.D/M.S. in Cell Biology, Immunology/Biochemistry with a minimum of 5 year of pharma/biotech industrial experience in functional biochemical/cell-based assay,  potency assay development, tissue culture, method qualification, validation and transfer to QC or CMO.

Job Responsibilities:

• Must bean innovative and motivated hands-on working professional to perform cell based bio-assay Development. This position oversees 3-4 scientists and directs all aspects of bio-assay development, specifically involving expert knowledge of immunoassays, cell-based protein mechanisms, applied advanced scientific principles, theories, concepts, practices and biologics product development.
• Must assist Formulation, Analytical and Process Development groups in the characterization and determination of activity of biological/proteins.
• Must be responsible for organizational responsibilities of the biologic bio-assay group development, successful inter-departmental interactions and meeting project time lines.
• Must review and provide scientific assessments of development reports, physical and biochemicalresults, stability data, batch records and protocols. 
• Candidate must have knowledge in writing & reviewing chemistry, manufacturing & control sections of INDs, CTAs, NDAs & annual reports.  Excellent communication skills, both written & oral.

Job Requirements:

• An in-depth knowledge of: cell biology, tissue culture immunoassays, flow cytometry,  receptor assays, ligand-binding assays, cell-based assays, reporter constructs, signal transduction, potency assays and Biacore / surface plasmon resonance to monitor biologics activity. Strong scientific understanding and experience with the use of biological assays to probe product quality, structure/function relations, and stability-indicating properties, particularly with protein biotherapeutics derived both from mammalian cell culture and fermentation processes.  Experience with comparability studies and regulatory filings preferred. 
• Expertise in exercising independent/proactivejudgment to determine the most appropriate course of action including technique and method selection, protocol and study design and execution, in-depth data analysis in assay development.
• Up-to-date knowledge of biopharmaceutical development and the state of the art in scientific biologic assay methodologies, with the ability to independently evaluate and develop in-house new bio-assay  methodologies
• Hand-on experience in data analysis and statistical programs; Softmax, Statview, Statlia, and PLA-2. To consolidate and analyze data from various sources, draw conclusions, and recommend scientific interpretations of activity assay data.
• Expertise in method development applied to functional and biological protein attributes including immunoassay development on a variety of platforms and cell-based potency assays.
• Ability to work well both independently and in a cross- functional team environment.
• Ability to prioritize work and multitask. Conducts work in compliance with safety and regulatory requirements and GLP and cGMP requirements.