MindPharm is partnering with an established BioPharmaceutical company to identify candidates for the in vitro Biology Cancer Research group to augment the discovery and development of innovative treatments to help patients in the fight against cancer.
We are currently seeking a highly motivated cell biologist to join our Cancer Biology group within the Cancer Research Division. The incumbent will be expected to identify and validate novel cancer targets as well as develop biochemical and cellular assays to support lead discovery and optimization. The individual must be able to prioritize and manage multiple research activities. Experience in DNA metabolism (repair/replication), apoptosis, cell cycle and/or other signal transduction pathways related to oncogenesis is essential.
The grade level will be commensurate of the individual's experience.
Independently guide the development of novel target candidates; develop and maintain appropriate in vitro assays to guide SAR studies; interact with cross-functional teams to facilitate lead advancement; critically evaluate relevant scientific data and apply this knowledge to research efforts; contribute substantially to the overall research strategies; continually implement and validate novel research approaches to advance project goals; communicate results to multi-disciplinary teams; publish project-related research in peer-reviewed journals.Skills/Experience
- Ph.D. in Cell Biology or related discipline with 3 years post-graduate experience in the area of cancer is required.
- Demonstrated scientific achievements, i.e., strong publication and/or patent record.
- Proficiency in standard biochemical, cellular and molecular techniques are highly preferred.
- Strong communication and teamwork skills are essential.
For consideration please contact;
Posted by Stephanie at 08:45 PM. Filed under: Science
MindPharm is partnering with a large, diversified BioPharmaceutical company to identify candidates for an exciting opportunity to join the Quality Assurance team and to lead vendor compliance fro Global R&D.
- Assure that GPRD remains in compliance with Corporate and Divisional policies and procedures and all applicable worldwide regulations
- Provide consultation and assistance to GPRD personnel on compliance issues.
- Provide GPRD personnel with training on applicable worldwide regulations.
Lead cross-functional project teams to help identify potential issues and resolve current issues.
- Manage compliance issues in Global Project Team/Functional Area programs, escalating issues to GPRD QA management as appropriate
- Responsible for GCP vendor management activities including vendor qualification, performance and ongoing performance monitoring through onsite auditing, metrics and KPI assessments.
- Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures
- Plan, organize, and lead multiple audits of R&D facilities, equipment, personnel, methods, practices, computer systems, procedures, records and controls for compliance to protocols, policies, SOPs, and applicable governmental regulations globally
- Evaluate the potential risk of compliance deficiencies across protocols and/or compounds within assigned Therapeutic Area/Program, utilizing tools such as metrics and trending of audit findings, and communicate compliance risks to GPRD QA management
- Identify services, maintain audit schedule, plan, organize and lead audits of external contract facilities (specialty testing laboratories, central laboratories, clinical sites, central Institutions, Review Boards (IRBs), Contract Research Organizations (CRO) and distributors as applicable) both within the US and globally
- Communicate Contract Research Organization (CRO) status to GPRD QA management, follow up on ongoing Corrective Action Plans with Suppliers and participate in strategic initiatives involving CROs
- Maintain effective communication of program related information
- Review corrective action plans/audit responses for adequacy and approve if adequate
- Review policies and procedures and suggest improvements
- Create quality/compliance training programs for the GPRD organization
- Identify, initiate, manage, and/or participate in quality improvement projects
- Work independently as well as a team
- Mentor, coach and train QA auditing staff
- Prepare and present multiple project progress reports to update management and keep the team(s) informed
- Maintain project oversight to include assessments for the development program, allocation of QA resources and awareness of project timelines
- Supervise Quality team members for project specific activities as required.
Directly coordinate GPRD GCP Compliance auditing programs
- Assist with the definition of GPRD Quality Goals.
Accoutability and Scope:
This position is accountable to the Director of GCP Compliance, GPRD QA. The decisions and recommendations made by the individual will directly impact compliance to applicable regulations, and thereby promote the continued success of GPRD. These activities such as auditing and associated functions can have a great impact on the quality of the data, which can, ultimately, lead to delay, or inability of company to market new products.
The job requires knowledge of quality principles, research, and the development of pharmaceuticals and an understanding of the effect of his/her decisions on it.
The individual must be able to:
- Work independently, in a team environment, and with all levels of personnel within the organization
- Effectively handle multiple assignments simultaneously
- Anticipate and adjust to rapidly changing priorities and anticipate the impact of the change on overall program
- Demonstrate a thorough knowledge of the applicable regulations and be able to apply them to a wide variety of situations
- Successfully interact with all levels of personnel within the division
- Show initiative to identify and implement new approaches to resolve problems (i.e., risk assessments, CAPA plans)
- Proactively identify issues across protocols and/or compounds;
· Utilize innovation in solving problems.
Must be able to make decisions with limited supervision, but decisions may be discussed with GPRD QA Management prior to implementation of action plan.
Bachelor’s Degree in a physical science, life science, nursing, pharmacy or equivalent experience required.
For consideration please contact;
Posted by Stephanie at 11:36 AM. Filed under: Current Opportunities