PRIMARY PURPOSE OF POSITION:
This position is responsible for recommending, developing and implementing novel/improved technologies for higher order structure characterization for the biologics portfolio candidates at Santen. She/he is expected to be well-versed with current regulatory expectations and industry trends for biologics characterization, comparability, and critical quality attribute determination. The candidate will also be expected to contribute to IND/IMPD and BLA/MAA authoring for the biologics portfolio candidates. The candidate will have opportunity to actively partner with various external organizations.
MAJOR DUTIES OF POSITION:
• Responsible and accountable for analytical development of biologics candidates in both early and late phases to launch. This includes Structural Characterization, CQA assessment, Comparability, Mechanism of Degradation.
• Contribute to authoring and reviewing technical sections in IND, BLA, MAA
• Plan and lead studies towards novel technology development for higher order structure characterization by analytical, biophysical, and mass spectrometry techniques.
• Ensure all experiments and activities are documented appropriately to ensure full traceability of work performed at the CMO/CRO.
• Work effectively with team members and contractors both in person and remotely. Provide direction, support, and corrective action as needed.
• Ensure that all processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures.
• Have a high level of scientific curiosity and keep informed of technical developments within the industry by attending conferences and reviewing papers thus advocating a culture of continuous improvement.
KNOWLEDGE AND SKILL REQUIREMENTS:
• PhD in Chemistry / Biochemistry or related discipline with minimum of 8-10 years of relevant experience in biopharmaceutical/biotechnology development
• Direct experience in authoring regulatory filing documents such as IND/IMPD, BLA/MAA
• Proven hands-on experience in biologics characterization including tools for higher order structure determination
• Proficiency in biologics separation techniques (such as chromatography, electrophoresis, glycan analysis) is a must
• Demonstrated hands-on experience with purification techniques including operation of AKTA and UF/DF systems as well as analytical methodologies (SDS-PAGE, HPLC, spectrophotometry).
• In depth understanding of charge and size based separation mechanisms and manipulation of operating conditions for optimal separation of target protein from process and product related impurities.
• Demonstrated in-depth understanding of primary, secondary and tertiary protein structure and post translational modifications.
• Highly flexible, works well in a team environment, and has the skills necessary to organize, communicate and influence, with an unquestionable level of integrity.
• Demonstrated proficiency in oral and written communication, an innovative problem solver and proven ability to recognize and recommend areas for improvement.
• Ability to deliver objectives on time in pressurized, fast-paced environment, while also meeting all compliance, quality and cost targets.
• Knowledge of quality systems and FDA/EU regulations as they relate to process / product development and manufacturing of biologics.
• Experience in defending processes, procedures and investigations during FDA/EMA inspections – experience with preparation for PAI’s and inspection support a strong plus.
• Demonstrated technical proficiency, scientific creativity, and innovation individually and in collaboration with others.
This section requires quantitative data that will help provide some measure of the size or scope of the position. Data should be on an annual basis.
List working relationships inside/outside of the organization other than your Direct Manager:
• Process Development, Non-clinical, Clinical, Regulatory, and QC/QA team members in the company
• Analytical development, QC, and other team members at CMO/CRO
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. The individual must be able to:
• Lift and move up to 25 lbs.
• Sit, stand, kneel, stoop, walk, use hands to finger, handle, or feel, point, and reach with hands and arms.
• Use the telephone and communicate clearly with a host of external individuals, domestically and globally.
• Work at computer for extensive periods of time.
• Work in a fast paced working environment managing multiple tasks.
• May require up to 30% travel; domestic and global, at times on short notice.
WORK ENVIRONMENT and ENVIRONMENTAL CONDITIONS:
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.