Overview

We are seeking an experienced Director- Technical Operations (MS&T), to provide scientific leadership expertise for our CDMO drug-product technical operations team which covers all manufacturing and packaging functions. The Middletown facility will produce oral solid dosage and sterile products. The person should be a customer focused with responsibility to set transfer strategy, ensure compliance with all regulatory requirements, deliver reliable processes, and drive continuous improvement across people, processes, and technology. This role drives compliance with Good Manufacturing Practices (GMP), regulatory standards (FDA, EMA, ICH), and company policies.

Responsibilities

Key Responsibilities:

New Product Introduction and Co-line Evaluation

Manage the process of new product introduction and co-line evaluation.
Guide department employees in reviewing and assessing the new product introduction information provided by the R&D department. For complex cases, organize communication and coordination with key personnel from relevant departments to make decisions.
Guide department employees in drafting co-line evaluation reports. For complex cases, organize internal discussions within STA to make decisions and communicate co-line strategies with customers.

Technology Transfer (Clinical Projects)

Manage the technology transfer process of clinical projects from R&D to production.
Upon receiving clinical project production requirements, allocation TO support personnel based on the project's characteristics and department resources.
Guide department employees in drafting batch production records based on the process research data provided by the R&D department.
Regularly summarize and analyze the execution status of clinical projects (with a primary focus on quality and efficiency indicators) and communicate with R&D management team.

Technology Transfer (PPQ Projects)

Manage the technology transfer process of PPQ projects from R&D to production.
Guide department employees in leading and implementing PPQ phase technology transfer projects, including technology transfer strategies determining, project scheduling, document drafting and approval, problem-solving, and project communication and coordination.
Continuously monitor the progress of PPQ projects and regularly report to production management.
Regularly summarize the execution status of PPQ projects and organize joint review meetings with R&D management.

Cleaning Verification and Cleaning Validation

Manage the processes of cleaning verification and cleaning validation.
Guide department employees in completing the daily tasks of cleaning verification, including drafting cleaning verification protocols and reports, performing cleaning sampling and sample submission, and communicating information with Production/QC/QA.
Guide department employees in leading and implementing cleaning validation work, including determining cleaning validation strategies, drafting cleaning validation protocols and reports, daily monitoring of cleaning validation, and annual reviews.
Continuously track the execution status of cleaning verification/validation and regularly report to production management.

Commercial Project Support

Manage the processes of continuous process verification and annual product quality review.
Guide department employees in continuously collecting and analyzing process data and drafting continuous process verification reports.
Guide department employees in leading and implementing the drafting and approval of annual product quality review reports.
Guide department employees in providing technical support for routine production, including drafting and evaluating changes, investigating deviations, and improving processes.
Provide technical guidance for complex issues in the commercial production process.

Audit, Registration, and Regulatory Support

Organize customer and official audits within the department responsibility, including pre-audit preparation, responding to questions during the audit, and post-audit corrective actions.
Organize product registration support within the department responsibility, including drafting and reviewing registration documents, responding to supplementary requests, and conducting supplementary study or validation.
Continuously monitor regulations and guidelines relevant to the department’s responsibilities and organize discussions and implement updates to internal processes as necessary.

Qualifications

Required Qualifications:

BS/MS in Pharmacy or chemistry-related major, familiar with pharmaceutical production, including manufacturing and cleaning processes, proficient in lean production management methods. (advanced degree preferred).
10+ years’ relevant work experience in the field of pharmaceutical production technology.

Knowledge / Skills / Abilities:

Strong hands-on leadership style
Proficient in oral & written communication skills
Demonstrated ability to read, write, and speak English
Proficiency in Microsoft Office (Excel, Word, Outlook)
Possesses basic knowledge of statistics and understands its practical application methods in the field of pharmaceutical production.
20% travel is required: both domestic and international
Strong knowledge of regulatory requirements (FDA, EMA, ISO).
Excellent problem-solving and critical-thinking skills.
Strong leadership, communication, and project management skills.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

Need help finding the right job?

We can recommend jobs specifically for you! An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability Click here to get started.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

Director Manufacturing Science and Technology Operations (MST)