Job Ref. ID:
Manager - Analytical Technology Transfer
Manufacturing Science & Technology (MS&T)
UNITED ARAB EMIRATES
UAE (RAK head office)
Manager - Analytical Technology Transfer
Full Time Employment (Un-limited Contract)
Analytical Technology Transfer Manager (ATTM) to lead analytical method tech transfers, validations and support investigations.
The ATTM works within a matrix team environment, coordinating activities to meet the goals of the MS&T teams. Expertise in analytical methodologies associated with the in-process, release and stability testing of APIs and drug products is required. In addition, skilled project management and communication skills are a necessary to be successful in this role.
Manage the analytical technology transfer team to ensure smooth execution of client projects according to budget and timelines given to the project team. Support follow-up and troubleshooting on analytical methods. Support process, pharmaceutical development and pre-formulation studies with chromatographic methods, technical expertise and solutions. Compile and analyze experimental data to generate process knowledge and decide on next steps. Prepare and present project updates to the stake holders and to higher management.
Key responsibilities & Accountability:
• Author, review or approve analytical method validation and transfer protocol and reports ensuring sound scientific design, compliance with ICH, pharmacopeia and regulatory guidelines, industry best practices, and Julphar internal procedures.
• Check the complete technical package, Coordinate transfer of information and materials related to analytical method validation and transfer.
• Participate in selection of suitable CMOs for manufacturing of drug candidates for GMP and commercial manufacturing.
• Define strategy and plans for processes leading to high quality drug substance with targeted Critical Quality Attributes.
• Prepare technical reports and CMC sections for regulatory filings
• Track the progress of analytical method validation and transfer projects, openly communicate updates, risks and mitigation strategies to stakeholders and management.
• Assist or lead OOS and OOT investigations as a technical subject matter expert. Travel to manufacturing and testing sites as appropriate.
• Author and review analytical method descriptions and validation summaries for international regulatory filings; Author and review responses to regulatory questions.
• Assess, compare, and perform risk assessments for compendial method compliance according to USP, EP and BP
• Assess analytical methods and perform gap analysis on analytical method validations for newly acquired programs. Develop project plan and timelines for method improvements and mitigation to ensure program milestones and deliverables are not impacted.
• Ensure that the required initial and continuing training of the department personnel is carried out and adapted according to the needs of the Organization in coordination with HR and training
• Define an optimum organization structure for the function, so that resources are optimally utilized and communications can be executed in an efficient manner.
• Review and ensure that operational and administrative practices, policies and procedures across the division are being followed by all employees
• Bachelor’s degree in Chemistry/ Biochemistry /r Pharmacy.
• Post graduates in Chemistry, Biochemistry or pharmacy is a definite advantage.
• At Least 8-10 years of experience in Pharmaceutical Industry is required, with major expertise in chromatography and spectroscopy.
• Should have handled similar role for better fitment of this position.
• Proven experience in analytical methods used for in-process, release and stability testing of pharmaceutical APIs and drug products such as HPLC, UPLC based assay and impurity methods, dissolution, content uniformity, particle size distribution, Karl Fisher, and residual solvents.
• Must be experienced in managing complex and sensitive operational challenges.
• In terms of Competency you are highly result oriented with strong sense of accountability & ownership.
• Motivated and highly organized professional and should be able to juggle competing priorities, with high level of integrity and professionalism.
• Strong organizational, planning and technical skills required.
• Excellent communication, interpersonal and presentation skills.
• Business acumen partnered with a dedication to compliance is essential for better fitment.
• Having an analytical mind with ability to think diversely, resolve problems with outstanding planning skill to manage & expedite complexities of procedures and regulations.
• Having excellent project management skills with the ability to track multiple programs and projects simultaneously.
• Ability to work under pressure, plan personal and team workload effectively and delegate.
• You are a team leader with a proactive and collaborative approach.
• Extensive knowledge of ICH and regulatory guidelines, pharmacopeia, and industry best practices for analytical method validation and transfer.
• In-depth knowledge of the industry's standards and regulations guidelines excellent knowledge of reporting procedures and record keeping.
• Strong Knowledge with GMP compliance and data integrity requirements (21 CFR Part 210/211, Part 11)
• Extensive knowledge of analytical procedures lifecycle management & specifications setting.
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