• The CMC Project Manager has an overall responsibility for managing key activities across CMC disciplines, including formulation and analytical development, CMO selection and Tech transfer to CMO, clinical Trial manufacturing and CMC documentation for regulatory submissions.
• Formulation design/development.
• Write and review documents for INDs / regulatory section submissions.
• Prepare, review or edit cGMP batch records, CMC regulatory and Quality documents.
• Establish and manage integrated CMC timelines for formulation development, analytical development, clinical trial manufacturing and release of clinical batches.
• Serve as departmental point of contact for securing internal review and approvals.
• Contribute to budget development and control for all CMC activities.
• Assist in finding innovative solutions to problems.

Requirements

• At least 10 years relevant experience in a pharmaceutical CMC/cGMP environment with projects in clinical development, Phase 1 through Phase 3, including multiple pharmaceutical dosage forms (e.g. tablets, capsules, topical, etc.)
• Substantial experience in managing International CMOs for the manufacture of cGMP Drug Product.

• Experienced with cGMP manufacturing ; IND, CTA and NDA filings; thorough knowledge of relevant FDA and EMEA regulations.

• PhD or MSc Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutical Science, or related scientific discipline.

• Excellent written and verbal communication skills in English.

• Exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators).

• Perform analytical method development, validation and analytical methods transfer activities to CMO/CROs
• Write and review technical reports, protocols, certificates of analysis, and deviation reports
• Initiate necessary change control processes/procedures and SOPs development pertaining to Analytical /Laboratory support activities
• Operate a wide variety of analytical testing instrumentation (HPLC, Dissolution – must, GC, MS, FTIR, etc.) by following standard analytical procedures
• Coordinate and interact cross-functionally within the company internal unit including RA, QA, pre-clinical and clinical

Requirements

• Master degree in Chemistry or related discipline
• 3 years or more in the pharmaceutical industry focusing on analytical laboratory activities associated with new project development, commercial manufacturing and tech transfer activities
• Experience in characterization of sustained release oral dosage forms (advantage)
• Hands on knowledge of analytical / laboratory testing including chromatographic methods and dissolution (must), analytical method development and validation
• Thorough understanding and familiarity of the current analytical methods used for API and drug products
• Experience in product development and working in accordance with GLP and GMP requirements
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists with minimal guidance
• Proficiency in instrumental Data Stations and Microsoft Office Suite
• Strong oral and written communication skills, in English

• Leading, in collaboration with Management, the process to establish product strategy, leading TPP creation and defining key inflection points
• Ensuring strategic and operational alignment: defining and ensuring that development plan is aligned with strategy and supports achievement of project goals and inflection points in the most efficient way.
• Planning and execution: responsible for definition of deliverables, making sure project plan is aligned with project KPIs. Monitoring key milestones, adjusting plans, if necessary, in order to deliver on schedule with the allocated budget.
• Risk management: ensuring that the risks are identified on time and that the contingency plans are in place and are communicated to the stakeholders on time to give them time to react.
• Team effectiveness: managing project team interactions, ensuring smooth communication, leading the project meetings, leading efforts in problem solving and driving the team to give their best.
• Communication: effective communication about the project within the company and in external forums.

Requirements

• MD or PhD – a must
• 5+ years of experience in leading product development in the Pharmaceutical or Biotech industries. Experience with combination products is an advantage.
• Understanding of drug product development aspects (from CMC to preclinical, clinical, Regulatory and launch preparation aspects.)
• Fluent English
• Creative problem solving.
• Strong communication and leadership skills

• Design of the phase 1 study (synopsis) to support project development
• Support CRO selection process for Phase-I studies
• Lead and manage the study planning activities
• Be a point of contact between the CRO and Clexio team
• Lead the review and finalization of study-related documents (Protocol, ICF, CRF, etc.)
• Manage communication and overall execution of the study according to the study plan until completion, in line with regulatory requirements and internal guidance
• Manage CRO and any external service providers that are involved in the phase 1 study
• Together with the CRO and Clexio’s project team, ensure that the study is in accordance with predetermined/set timelines & budget
• Thorough review of the study data (review data listings, eligibility of subjects, safety results, etc.)
• Upon study closure: leading the review of Clinical Study Report (CSR)

Requirements

• Master’s degree in Chemistry or related discipline
• 3+ years in the pharmaceutical industry focusing on analytical laboratory activities associated with new project development, commercial manufacturing and tech transfer activities
• Experience in characterization of sustained release oral dosage forms (advantage)
• Hands-on knowledge of analytical / laboratory testing including chromatographic methods and dissolution (must), analytical method development and validation
• Thorough understanding of and familiarity with the current analytical methods used for API and drug products
• Experience in product development and working in accordance with GLP and GMP requirements
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists, with minimal guidance
• Proficiency in instrumental Data Stations and Microsoft Office Suite
• Strong oral and written communication skills, in English

come join us