The position is technically detailed, requiring the services of an individual who can qualify as a specialist, with a minimum of three years of product research and development experience. This technical position requires advanced educational training and experience and champion innovative therapeutic opportunities consistent with company business plan including evaluation of published development and innovation.

BASIC QUALIFICATIONS

Ph.D. or M.S. in pharmaceutics or relevant field with minimum of 3 years of experience (preferably in formulation designing and execution which includes preformulation and formulation related to pharmaceutical product development)

SALIENT RESPONSIBILITIES INCLUDES, BUT NOT LIMITED TO

• Identifying and proposing suitable product development opportunities based on available clinical trial data, relevant patent information, technical feasibility and potentially market viability in the literature.

• Developing intellectual property offerings that combine technical innovation and real-world experience.

• Developing new products by creating and expecting project plans to include interaction with customers, literature searches, laboratory and pilot experimentation, and cooperation with support groups to meet timing, budget and product performance expectations.

• Conceptualizing, formulating, developing and evaluating pharmaceutical dosage forms and products.

• Executing leadership qualities / skills to manage pool of product development activities.

• Writing SOPs, work instructions for laboratory, technical reports and other documents necessary for product submission to FDA and equivalent regulatory agencies.

• Perform all documentation practices in compliance with cGMP.

• Supporting and coordinating with various work forces such as marketing, operations, engineering within Spriaso or other contract manufacturing organizations.

• Experience with HPLC, related spectroscopy and other common analytical methods and experience in manufacturing of dosage form for clinical trials and scaling up to commercial scale is preferred.

Responsible for the design and conduct of all analytical activities including scheduling, planning, and monitoring the operations of the department to ensure that the analytical functions are accomplished with high scientific quality and in compliance with all applicable regulatory requirements, while meeting company timeline.

BASIC QUALIFICATIONS

Ph.D. in Analytical Chemistry with 3-6 years experience in product development in the Pharmaceutical Industry. Strong background in analytical chemistry and experienced in development/validation of various analytical methods for pharmaceutical products. Knowledge of cGMPs/GLPs and FDA guidelines as they relate to method development/validation and product registration.

SALIENT RESPONSIBILITIES INCLUDES, BUT NOT LIMITED TO

• Development of analytical methods for excipients, API, intermediates and products.

• Validation of analytical methods, and the successful transfer of methods to Partner/Contract Manufacturer.

• Testing and release of excipients, API, intermediates and product for clinical supplies manufacture and clinical studies.

• Conduct of stability testing on API, intermediates and finished product in development.

• Prioritization of the analytical workload in the group.

• Implementation of new analytical techniques, laboratory equipment/automation which improve the efficiency/productivity of the laboratory.

• Ability of handle multiple projects with tight/overlapping timelines.

• Represents Spriaso at scientific, partner, contractor or regulatory meetings as appropriate.

• Effectively manage and supervise analytical chemists and serve as mentor and aid in the development of analytical chemists.

• Select and manage the use of outside contract laboratories to effectively extend the analytical capabilities of the laboratory.

• Design/upgrade appropriate laboratory facilities to meet lab objectives.

• Maintain effective communications with appropriate managers so that a team working environment is created for the development and registration of new products.

• Knowledge and familiarity with outside contract laboratories and their capabilities

• Knowledge and familiarity with overall pharmaceutical product development process and regulatory requirements particularly as they relate to CMC issues.

• Supervisory experience and laboratory management experience desirable

These positions entails doing product, process, and analytical functions in support of product and technology development under direction of product development and/or analytical leader. The ideal candidate would possess:

• Strong computer, scientific, and organizational skills

• Excellent communication (oral and written) and attention to detail

• Ability to work independently and as part of a team with internal and external clients, self motivation, adaptability, and a positive attitude

• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

BASIC QUALIFICATIONS :

Bachelor's degree in chemistry, chemical engineering, biochemistry, or other related degree concentration, or equivalent directly-related experience with at least one year related experience in pharmaceutical industry

SALIENT RESPONSIBILITIES INCLUDES, BUT NOT LIMITED TO

• Perform physical, chemical, and instrumental analysis of active pharmaceutical ingredients and finished pharmaceutical products (tablets, capsules, parenterals, devices, aerosols, liquids, creams, and gels)

• Assist with literature searches, formulation design, manufacturing testing supplies, conducting preformulation studies, dissolution assessment, analytical method development.

• Manage lab activities including lab supplies, procurement and maintenance of lab and manufacturing equipment.

• Run the instrumentation independently including, but not limited to, various chromatographic systems, Karl Fischer (Coulometric and Volumetric), UV/Spec, various wet chemistry analyses, HPLC, IC, IR, ICP, AA, TGP, DSC, PDA, auto-titrators, TLC, and dissolution apparatus.