Job Opportunity - Manager API Process Development & Manufacturing
Location: Athlone
Job type: Permanent
Salary: Competitive / Based On Experience
Discipline: Active Pharmaceutical Ingredients
Reference: MER_2201
Introduction
An exciting opportunity for a Process Development and Manufacturing Manager interested in joining an Irish, specialty API start-up. Arbutus Innovation Centre is advertising this position on behalf of Mercury Rising Limited, an exciting start-up, servicing a niche, fast-growing global industry with new APIs. This is an exciting opportunity to work in a fast-paced environment with a small, collaborative and dynamic team of innovators and experienced leaders.
In this role you will provide technical discipline leadership and will direct the day to day operational activities of the API manufacturing department, as well as actively manage the department’s quality and efficiency. This is a full-time permanent role based out of Athlone, Ireland with flexible scheduling, ensuring the right work /life balance for you.
You will need to have excellent GMP knowledge, API manufacturing experience, chromatography experience and be able to provide technical support to the operational areas and engineering personnel to ensure operations are conducted efficiently, and approved production and project schedules are achieved.
The Successful Applicant
The successful candidate will have a background in organic chemistry, excellent GMP knowledge, chromatography experience and a significant track record of supervisory management in a Pharmaceutical manufacturing environment.
Job Summary:
The API Manufacturing Manager will lead, coordinate and direct all site start-up and manufacturing activities on a new site in Athlone.
Collaborating with the team, you will develop efficient processes and improvements for the manufacturing of speciality, small molecule APIs. This is a leadership role with focus on the start-up and execution of GMP operations, ensuring the facility is accurately staffed and trained and supporting a production planning process. You will be responsible for meeting production schedules and the coordination of related operations. Working with Senior Management and the Operations Director you will support the overall vision and initiate improvements to ensure the processes meet present and future requirements for quality, growth, flexibility and cost improvement.
Qualifications
B.S. or M.S. in Scientific/Engineering Discipline with strong knowledge of organic chemistry and small molecule batch manufacturing technology
5+ years Industrial experience in technology development, scale-up & manufacture of pharmaceutical & speciality chemicals in a cGMP environment
Prior management experience in a relevant pharmaceutical manufacturing, healthcare or pharmaceutical environment.
Significance experience working with chromatography and evaporation techniques
Previous experience with multi-product API facility
Technical process and product introduction experience
Some knowledge of LEAN and 6 sigma manufacturing principles
Well-developed communication (written & oral) and interpersonal skills. With the ability to work effectively with staff at all levels of the organisation
Excellent organizational and problem solving skills (think outside the box).
Highly analytical and structured way of working
Experienced in managing/collaborating in interdisciplinary/matrix organisation
Experienced in manufacturing under ICH cGMP guidelines for APIs
Experience in operations management, effectiveness, process justification, process validation, and equipment qualification
Responsibilities:
Management of the Process Development & Manufacturing of small molecule Active Pharmaceutical Ingredients in support of commercial distribution
Manage and collaborate with plant operations personnel ensuring they are adequately trained, equipped, and motivated so that the production plan can be delivered daily.
Compliance with Quality Management Systems (GMP/ICH Q7) & EHS policies
Establish & monitor KPI's to drive continuous improvement
Manage organisation to support evaluation & development of proposals with direct responsibility for establishing timing
Maintain strong working relationship with management, analytical chemistry, quality control, EHS & quality assurance to achieve deliverables & targets
Maintain technical/business relationships with clients
Utilise business systems and software tools to analyse reports on production.
Provide technical support on the development and introduction of new products and processes
Designs systems and assist in the execution of QC sampling.
Promote a safety-first culture, quickly identify & resolve any safety hazards.
Ensure safe work practices are observed and ensure the requisite PPE is worn within designated areas.
Report accidents/incidents/ observations and complete any documentation as required.
Conducts employee performance reviews based on job descriptions to determine competency, knowledge, and contribution of production personnel.
Raise purchase requisitions relevant to the manufacturing process and GRN same.
Identify and implement Capital Improvements in conjunction with the wider management team.
Maintain accurate inventories of raw materials and collaborate with the wider team to carry out supply chain and logistics operations.
Monitor key production metrics such as throughput, downtime, production schedule compliance, etc. and initiate improvement plans where required.
What's on Offer
Excellent opportunity to operate at senior level within a rewarding industry sector with ample opportunity for progression and learning.
Additional Information
To be considered for this position in Ireland you need to be legally eligible to work in Ireland.
Please note there is no relocation support available for this position.
Equal Opportunity Employers
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Arbutus Innovation Centre and its client companies are committed to celebrating this, in all its forms. We strive to build a culture that encourages, supports and empowers our employees.
Competitive Salary & Benefits:
Interested candidates should submit an updated CV.
Please click the link below to apply or alternatively send an up to date CV and cover letter to:
careers@arbutus.ie
IRELAND
Daneswell Business Park
Monksland, Athlone
Co. Roscommon
Republic of Ireland
Contact Us
If you have any questions related to this job opportunity or would like further information please contact us via careers@arbutus.ie or through filling out the form.