PK/ADA Scientist

Job description

Your New Company! At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences. We are better together and together We Are Altasciences. About The Role The PK/ADA Scientist II is assigned to projects based on scientific competency and training. The Scientist will ensure the overall integrity/quality of assigned studies. The Scientist can also be designated as the main contact for client interactions laboratory for their assigned projects. What You'll Do Here Autonomous and proficient developing, planning, managing, conducting, reporting and troubleshooting multiple assay types to ensure scientific quality, regulatory expectations, and client satisfaction Assigned by management on studies and tasks based on scientific competency and training (can include method development, validation or sample analysis projects). For validations and sample analysis the Scientist can be assigned as Bioanalytical Principal Investigator and is the first point of contact for PM and/or clients for laboratory services and will manage and conduct method development, qualification , validation and production studies for clinical and non-clinical studies in compliance with the protocol/study plan, amendments, GCP, GLPs, SOPs and Best Practices. Manage project and order appropriate material, as needed When applicable, provide QC support on studies assigned to other team members in laboratory based on training and competencies. When applicable, perform data batch review, perform multi-batch trend analysis, complete documentation as required by tracking deviations, events and reports of non-compliance and review or approved Memo to File or SOP/Protocol/Study Plan deviations. When applicable, provide a report and/or reporting of results, within study timelines and ensure any deviations/exception events are reflected as appropriate and assure that all analysis conducted is reported and is accurate. Manage as to maintain timeline and scheduling commitments When applicable review and provide comments and recommendations, as needed, for the bioanalytical portions of preclinical and clinical protocols, study plans, laboratory manuals, Data Transfer Agreements, and/or other document, as needed. Support and mentor Analysts in the daily operations for completion of sample analysis and/or validation studies and the analysts work. Support and mentor other team members based on expertise. Responsible for troubleshooting issues within the studies and be able to resolve them independently via development of appropriate procedure. Organize and communicate complex data sets in a clear and concise manner to key stakeholders from diverse backgrounds To write, review and updated method SOP as needed Participate in meetings with clients, conferences and scientific outreach Conduct applicable work in compliance with applicable SOPs, GCPs, GLPs, and observe all company guidelines and policies Respecting Health and Safety standards in terms of personal protection, laboratory maintenance, and work procedures; What You'll Need to Succeed Ideally College degree and/or University degree in Chemistry, Biochemistry, Immunology or applicable field. Minimum 3 years of experience in a pre clinical/CRO Knowledge of regulatory agency guidelines, must understand general SOPs and have excellent knowledge of GLP regulations. Good organizational skill, highly flexible, sense of urgency, excellent troubleshooting skills, client oriented, attentive to details, be able to easily read and understand study plans and protocols and ability to coach/mentor people. What We Offer: Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work. Altasciences' Benefits Package Includes: Health/Dental/Vision Insurance Plans 401(k)/RRSP with Employer Match Paid Vacation and Holidays Paid Sick and Bereavement Leave Employee Assistance & Telehealth Programs Altasciences' Incentive Programs Include: Training & Development Programs Employee Referral Bonus Program Annual Performance Review #LI-TA1 MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!