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  • Job reference: RMS0155721

Downstream Process Operations Principal Scientist

  • Sector: Engineering
  • Location: Billingham
  • Job type: Permanent
  • Date posted: 01/05/2015
  • Time left:
    d h m s
    (15/05/15)
This vacancy has now expired.
The Company:
One of the world's leading private biotechnology companies, developing and manufacturing innovative biotechnology-based medicines for human healthcare products, with a focus on microbial-derived biologics .

The Role:
Job Title: Principal Scientist
Department: Research & Development, Downstream Process Operations
Location: Biotechnologies, Billingham


PURPOSE OF JOB

To contribute to a R&D DSP Operations project team to provide high quality experimental work in the development, evaluation and characterisation of processes for the production of novel therapeutic products (particularly proteins).

DIMENSIONS

Staff: 2-4 DSP Research Staff, Occasional supervision of placement students where applicable.

Forward work plan: 4-6 months.

Key techniques / expertise:

In-depth theoretical and practical knowledge of Biochemistry, Cell Science, Protein purification, Biochemical Engineering and associated analytical techniques.

Ability to utilise a range of Downstream Processing equipment and techniques to enrich and purify a plethora of molecular classes pertinent to the biopharmaceutical and healthcare industry.

Ability to perform calculations (e.g. molarity, use of formula weights, buffer composition, mass balances statistics biomass, specific production rate, growth
rates).

Additional departmental specific requirements for this job role can be sought from your line manager but may include aspects of lab management, Quality or EHS advocacy.

ACCOUNTABILITIES

1. To identify, design, implement and manage experimental development programmes needed to develop, evaluate and characterise new processes for target molecules.
2. To review experimental work, data and reports produced within R&D to ensure accuracy and compliance.
3. To carry out process technology transfers from client companies.
4. To assess manufacturing processes supplied by client companies for suitability for GMP manufacture and identify any scale-up requirements/issues.
5. To prepare reports and presentations for internal & external use in a suitable and professional manner.
6. To train and supervise the experimental work of other junior research staff.
7. When required, participate in the technology transfer process to enable clinical manufacture of the target molecule, using the novel purification process, within the GMP
environment. This may require direct involvement in clinical manufacture as an ABC1000 secondee.
8. To produce batch records for GMP manufacturing processes.
9. To advise senior management, technical project leaders, programme managers and other principal scientists on the feasibility, suitability and efficacy of the downstream
processes being developed.
10. To co-ordinate work with other functions / departments to achieve project objectives.
11. To be compliant within the cGMP system.
12. To work safely and in accordance with SHE polices and keeps up to date with any SHE issues.
13. To maintain an up to date knowledge of developments which may impact on the technologies involved in the processes being developed


SPECIAL FEATURES

1. Project based, multidisciplinary team organisation with job holder reporting to the technical project leader in regard to activities for which the job holder is responsible in the
project.
2. Significant regular client contact a feature of the job. The job holder must be able to interact satisfactorily with the client company personnel in achieving the
project targets. The job holder must be able to demonstrate technical and scientific knowledge to the client appropriate to the tasks being discussed.
3. The job holder will be operating in a highly regulated environment and must of
necessity maintain awareness of the regulatory background to their work
4. A relevant degree plus a minimum of 6 years laboratory experience or Ph.D. in biological, biochemical, engineering or chemical science or significant experience of
biochemistry and protein purification processes.

COMPETENCIES

Ability to learn; Analytical thinking; Critical information seeking; Results orientation; Thoroughness; Self-control; Concern for standards; Rational persuasion; Innovation; Tenacity; Flexibility; Independence; Inter-personal awareness; Self-development; Initiative;

PURPOSE STATEMENT:

An experienced scientist able to execute experimental work programmes to identify and develop novel processes for the production and analysis of therapeutic products.

REQUIREMENTS TO REACH EFFECTIVE PERFORMANCE:

GENERAL ATTAINMENT

A graduate with a relevant
degree and at least 6 years
relevant laboratory
experience or Ph.D.

JOB RELATED WORK / SKILLS/ KNOWLEDGE/REQUIREMENTS

In-depth knowledge of proteins,
Biochemistry and protein purification .

Extensive practical relevant lab experience.
TIME REQUIRED IN JOB
TO REACH EFFECTIVE
PERFORMANCE

1-2 years


SKILLS & KNOWLEDGE COMPETENCIES
Key Competencies

Safety policies e.g. COSHH and RISK Assessment, Good Manufacturing Practice (cGMP).

Laboratory skills: Ability to perform and teach calculations (e.g. molarity, use of formula weights, buffer composition, mass balances, biomass, specific production rate, growth rates). An appreciation for the theory underpinning conductivity and pH and an in-depth working knowledge of the key unit operations implemented in Downstream Process Operations i.e. buffer preparation and formulation, precipitation and clarification, refolding and solubilisation, dead-end and depth filtration, chromatography, refolding and ultrafiltration and diafiltration.

Planning horizon: 4 to 6 months plus work planning for staff

Communication: Well written, compliant, traceable laboratory note book
and raw data files. Be able to contribute effectively to the production of customer reports. To be able to present data to work groups and customers, when required.

Team skills: Ability to work effectively in a team and lead the DSP aspects of a customer programme.

Training: Laboratory equipment and maintenance; site-wide safety procedures; GMP Training will be provided when individuals are
required to work within a GMP compliant environment.

Problem Solving: Ability to define and analyse diverse and complex work related problems and propose and implement creative solutions based on experience and the application of fundamental scientific principles.

Management: Contribute to the development, training and motivation of other department staff from both a line and project management context. Top Five Competencies
-Analytical
Thinking
-Critical
Information
Seeking
-Results
Orientation
-Concern for
Standards
-Thoroughness

Other Key
Competencies
-Ability to learn
-Self Control
-Rational
Persuasion
-Flexibility
-Innovation
-Tenacity
-Inter-personal
Awareness
-Self-
Development
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