Our client is a very successful ambitious global manufacturer of innovative pharmaceuticals. With a strong commercial portfolio and drug pipeline, and a well-managed high performing, highly motivated workforce, driven by the highest operational excellence standards, this is an outstanding opportunity for a bright capable drug substance expert.
External Operations Team operates a model of Excellence through Partnership via the virtual plant operating in a dynamic and flexible environment where their collective role is to ensure the end-to-end integrity of the commercial supply network to deliver quality medicines to our patients in a safe, efficient and value driven manner where diversity, inclusion and belonging are core values to our organisation.
We are currently seeking a Drug Substance Technical expert responsible for being the technical lead supporting Active Pharmaceutical Ingredient (API) manufacturing at Contract Manufacturing Organizations’ (CMO’s) and Suppliers that provide API for subsequent processing in Drug Product (DS) processes across Oral Solid Dosage (OSD) and Injectables.
Required to provide technical leadership for Drug Substance (small molecule) for new product introductions, technology transfers, process scale-up, process monitoring and troubleshooting and improvement projects at CMO’s on behalf of our client.
- Provide commercial technical requirements for all molecules transitioning from Development to Commercial ensuring the link between development and ultimate commercial manufacturing is maintained throughout the product lifecycle by working closely with Process Development.
- Understanding of chemical processes from both scientific and engineering perspective demonstrating expertise in how API processes are developed and controlled to maximize yield and minimize impurities.
- Understand and identify key attributes of API material as it pertains to downstream processing in the drug product process.
- For new processes ensure that the process is well defined with appropriate identification of CQAs and CPP’s with appropriate measurement of both.
- Provide technical input into the commercial master batch records.
- Provide input into the Specification and Commercial Purchasing Specification.
- Provide technical input into Process FMEA and Change Risk assessments.
- Provide technical review of regulatory filings supporting CMC aspects of regulatory dossiers, providing input and guidance around the manufacturing control strategy prior to filing and process validation.
- Provide support to Validation team in validation planning and execution of APIs as needed as part of cross functional team involving Supply Chain, Quality and Validation.
- Support the manufacturing of API’s at CMO’s and Suppliers by monitoring process performance and providing technical expertise to ensure processes are understood, robust, efficient and in control.
- Provide technical review for all changes at CMO’s and Suppliers via the change control system.
- Provide Technical review of CMO investigations.
- Perform trending on CMO API processes and where appropriate identify opportunities for continuous improvement providing technical support to implement such improvements.
- Provide oversight of Engineering Studies/ Batches and associated protocols and reports at CMO’s.
- Maintain process control strategy documentation through the commercial part of the lifecycle of the API.
- Support CMOs in regulatory and external auditor inspections in conjunction with Quality and Validation leads and respond to observations as needed.
- Support the Operations leadership with project management and implementation of key technical projects which are identified as part of the company’s objectives in both CMOs and company facilities.
- Ensure technical activities are conducted in accordance with Commercial Supply Agreements.
- Ensure procedures for Technical Transfers are followed.
- In conjunction with Commercial Supply Chain, support network optimisation by providing technical expertise to determine supplier selection and technology transfers as required.
- Provide leadership to a small team within Technical Operations.
- Establish strong working relationships to build partnerships based on trust with CMOs through internally established communication forums.
- Partner with Commercial Supply Chain, Supplier Relationship Management, Quality, EHSS, R&D and other functions as required across the internal network to deliver value aligned with business goals.
- Develop recommendations for strategic/business decisions. Provide management with accurate and timely information necessary to make strategic, investment and operating decisions.
- Preparation of CMO competency assessment to ensure robust decision-making processes when it comes to supplier selection and supplier optimisation discussions with senior management.
- Facilitate the transfer of new products and development projects to sites through the development of effective business cases and management support.
- Preparation of credible and reliable business plans, budgets, and forecasts.
- Foster and promote internal collaboration.
- Ensure support and integration of Technical Operations with relevant functions in order to achieve customer service objectives.
Third Level qualification in chemistry/chemical engineering or relevant engineering/scientific discipline, preferably multi-disciplinary with a strong technical/scientific orientation.
Strong understanding and experience of technical/scientific challenges in production processes ideally across both Drug Substance and Drug Product processes with proven track record demonstrating issue resolution.
8-12 years’ experience in high volume/manufacturing/relevant environmental likely to include:
Pharmaceutical or Biotech with a minimum of 2 years at senior level.
Established track record with evidence of excellent project management, problem solving, collaborative, leadership and communication skills.
Process Safety in API environment.
Lean/Six Sigma qualification at Green Belt or above obtained and certified by an Internationally recognized body in a pharmaceutical / medical device setting.
Ability to foster and promote internal collaboration.
Ability to thrive in a virtual dynamic environment.
Logical and problem-solving skills.
High level of customer orientation/understanding.
Excellent interpersonal and communication skills.
Speaks clearly and persuasively in pressurised environments.
Active listener with ability to seek clarification where required.
Responds constructively to respectful challenge and engages actively in meetings with the ability to present in group settings.
CV to firstname.lastname@example.org