Must know process validation cleaning validation verification and hold time studies. Candidate should also have exposure to EU, MHRA, and USFDA regulatory audits.
To participate in sample processing for PK, ADME assays and handling of LCMS/MS. Ability to adapt to the dynamic team environment. Processing of different matrices samples of PK studies. Optimization of test compounds manually as well as automated on LCMS/MS. M.Pharm in Pharmaceutical sciences, Pharmaceutical Analysis who has interest and passion for LC/MS related bioanalysis
Proven track record of leading a large, geographically diverse sales team, including at least 2 years of experience overseeing half of India with a positive P and L outcome. Expertise in developing sales strategies, financial acumen, performance management, strategic project leadership, building and nurturing stakeholder relationships.
The candidate must possess a thorough understanding of relevant disease biology, the clinical landscape, emerging technologies, and the competitive environment.
Within this program you will thrive within a fast-paced, dynamic study design. As we are fully embedded with this global pharmaceutical client, you will experience a true one team approach that provides limitless opportunity to develop through training, mentorship, and support from leadership.
Responsible for execution of the study and system related activities as per the established Standard Operating Procedures, Good Clinical Practices, Good Laboratory Practices and regulatory requirements.
Integrate technological breakthroughs and consumer insights to develop new ideas, products, innovative technologies, solutions and communications that engage and delight the consumer, shopper, profession. Provide excellent support for all on-going and new product development projects & initiatives such as margin improvement programs to improve bottom line.
This also includes managing the Per-Subject Cost PSC process for assigned studies, managing escalation and resolution for budget and non-legal term issues from other ICL or pCRO and collaborating with other lines to plan site contracting timelines through start-up.
Must have hands on experience in working with chemical methods and handling instruments like Prep HPLC and HPLC. Expertise in HPLC & Prep HPLC method development and basic undersatnding in data interpretation of various analytical technique such as LCMS, GCMS, FTIR, UV-Visible, NMR etc is required.