Director, Technical Services

Summary

Responsible for activities related to process development and technology transfer for oral solid and/or liquid and semi-solid topical dosage forms. Utilize quality by design (QbD) principles to ensure products under development meet their critical quality attributes. Develop and maintain skilled research personnel capable of meeting challenges posed by assigned projects. Interface with Operations, Regulatory, Quality Assurance, Quality Systems, and Quality Control departments to complete experimental/optimization trials and the technology transfer of new and restart products to production. Provide input and support validation activities for new and restart products and processes. Interface with other departments as needed to develop and maintain safety and compliance procedures, develop quality processes and progress projects.

Essential Duties and Responsibilities

• Provide comprehensive formal and informal leadership to promote a positive work environment and communicate overall business expectations to all working groups.
• Plan, direct and monitor tasks related to process development, scale-up, process optimization, technology transfer and manufacturing support activities by incorporating QbD principles.
• Plan, direct and monitor product launch activities related to pharmaceutical manufacture of products being transferred from R&D to Operations.
• Direct and coach staff in areas such as quality, compliance, safety, project planning, process development, technology development, and application of appropriate in-process tests.
• Prepare budgetary projections for manpower, capital and active pharmaceutical ingredients, as required.
• Communicate effectively with executive management regarding compliance, project planning and status, as well as company and industry issues.
• Prepare departmental goals and objectives based on compliance, scientific design requirements, project timelines and milestones.
• Communicate effectively with Operations to aid in capacity planning for facilities and equipment.
• Build and maintain a staff of professional, highly motivated and knowledgeable individuals. Participate in selection of personnel and provide for their effective and thorough training. Establish standards of performance in accordance with company guidelines and evaluate performance against those standards for all staff members, to include preparing and conducting performance evaluations.
• Ensure staff is trained and qualified in regulatory compliance areas (QbD/GMP/GLP/DEA) and Standard Operating Procedures related to performance of duties through implementation of training and monitoring of results.
• Provide technical guidance to staff as required in areas related to process development, such as scientific design techniques, compliance, materials, equipment, preparation of clinical supplies, process development, scale-up, process optimization, and process improvement.
• Write and review SOPs, guidelines and work instructions as appropriate. Assure the department follows all applicable procedures and complies with regulatory agencies.
• Plan projects and work closely with other functional management to implement processes and maintain plans and timelines.
• Plan, assign and review development plans, research projects, specifications, development reports, and equipment selection with research staff and ensure compliance to sound scientific design principles through the establishment of adequate processes and procedures.
• Review and ensure the reliability of technical data related to formulation, process, analysis, and stability monitoring for new products and processes to be included in IND, NDA, and ANDA eCTD submissions.
• Coordinate with Regulatory Affairs or other departments to provide required information for government submissions or other regulatory agencies.
• Coordinate activities of the Technical Services staff with other groups within the Company to ensure the quality, timeliness and effectiveness of all activities.
• Direct the Technical Services staff to provide technical assistance to Operations as needed.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Perform other related duties as assigned to meet departmental and Company objectives.

KNOWLEDGE/SKILLS/ABILITIES

• Theoretical and working knowledge of pharmaceutical ingredients as well as manufacturing, processing and testing equipment, along with the necessary skills to design control strategies.
• Understanding of chemical and physical properties of active ingredients and excipients as they relate to formulation, process and drug delivery, and the control strategies needed to produce quality products.
• Working understanding of pharmaceutical equipment at lab through manufacturing scale.
• Theoretical and working knowledge of advanced process technologies well as the ability to develop quality processes using them.
• Working understanding of statistical techniques, including experimental design.
• Expert knowledge of scientific design techniques, cGMP and DEA requirements.
• Working knowledge of budget development and management.
• Proven leadership and interpersonal skills to effectively lead, influence, collaborate, and work with diverse teams and individuals at all levels throughout the organization.
• Highly organized with strong project management skills to effectively manage multiple priorities, projects and requirements in a fast paced, dynamic environment.
• Excellent communication skills to effectively communicate in a clear, concise manner whether in oral, written or presentation form.
• PC proficiency using Microsoft Office programs.
• Ability to design processes that ensure compliance to sound scientific Quality by Design (QbD) principles, regulatory agency requirements and company policies.
• Ability to work independently to forward the goals and objectives of the department and company.

EDUCATION/EXPERIENCE

• Master of Science degree in pharmacy, chemistry or related physical science preferred; or BS degree with significant, directly related experience with increasing levels of responsibility.
• Minimum seven years' experience in manufacturing, process development, and technology transfer in the pharmaceutical industry.
• Must have experience with an emphasis on process development, scale-up, process optimization, product transfer and product launch activities.
• Must have proven experience in technical support of manufacturing for oral solid and liquid dosage forms and semi-solid topical dosage form.
• Must have at least five years' experience in a managerial or supervisory capacity.
• Experienced in Quality by Design techniques for developing quality pharmaceutical product manufacturing processes.
• Wide working experience with typical pharmaceutical materials, equipment and processes.

Work environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

1. Stand, walk, sit, reach, talk, and hear.

1. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.

1. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

1. Normal office conditions.

1. Occasionally in a proximity to moving mechanical parts, laboratory equipment and exposure to chemicals.
2. Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

Current Openings for Director, Technical Services Jobs at Nesher Pharmaceuticals (USA) LLC