The essential job function is to communicate project goals to the teams, coordinate the tasks needed to meet the established project timelines assigned to the team, and mentor team members.
Aptalis is an Equal Opportunity Employer EEO/M/F/DV.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The primary duties and responsibilities of this position include the following. The Group Leader is responsible for the empowering of each member of the team to ensure the efficient operation of the group.
The Group Leader reviews and approves relevant analytical documentation.
The Group Leader writes and/or reviews technical reports, method transfers to and from QC and external laboratories, method development and project summaries, method validation protocols and reports, ANDA/NDA/DMF sections for inclusion in Regulatory filings and any other document necessary for the team.
The Group Leader is responsible for assignment of necessary and appropriate personnel and resources to allow timely and effective method development and validation.
The Group Leader performs necessary research of relevant literature.
The Group Leader is responsible for reviewing, updating and approving relevant SOPs
The Group Leader ensures that each member of the team is properly trained in the Aptalis Standard Operating Procedures (SOPs) needed for the tasks assigned to them. .
The Group Leader is responsible for facilitating the career development of the team members through training, mentoring, coaching, etc.
The Group Leader ensures the team is compliant with all regulations as specified by OSHA, EPA, FDA or other Regulatory Agencies, and as defined in the Corporate Hygiene plan.
The Group Leader is responsible for ensuring supplies and reagents needed to complete
the project tasks are available.
The Group Leader is responsible for the performance appraisals of members of the group.
The Group Leader provides the necessary support, opportunity, and resources for members of the group to meet their performance objectives.
The Group Leader is responsible for the smooth operation of the laboratory. This includes ensuring all laboratory equipment is properly calibrated and functioning smoothly.
The Group Leader communicates needs, issues, and updates to appropriate management and other personnel in a timely manner.
The Group Leader will interface with peers, supervisors, and subordinates in a professional manner.
The Group Leader will perform other tasks as requested by the Management team.
Produces value-added results through effective recruitment, delegation, performance management, training and development of employees.
EDUCATION AND/OR EXPERIENCE:
BS/BA in Chemistry or related field with a minimum of 10 years pharmaceutical experience
MS/MA in Chemistry or related field with a minimum of 8 years pharmaceutical experience
Or PhD in chemistry or related field with a minimum of 5 years pharmaceutical experience.
Some formal or informal supervisory experience is preferred.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Proficient in HPLC analysis, key trouble shooter.
Proficient understanding impurity analysis.
Proficient in dissolution testing.
Good understanding of GC
Thermal Analysis or DSC
Works independent of supervisor. Incumbent conducts programs and research projects that are stated in terms of general objectives with limited supervision.
Confidentiality of projects, tests results and both customer and Company information and data is required.
1. Physical Demands:
The employee is required to:
Have the capability to work frequently on the computer
Have the capability to travel by plane
2. Visual Ability:
Visual accommodation necessary for reading notebooks, lists, documents and and operating laboratory equipment..
3. License Required:
Valid Drivers License
4. Hearing Ability:
Must be able to hear alarms, detect machine sounds and malfunctioning equipment to identify and diagnose changes so appropriate action can be taken.
5. Working Conditions:
The employee is subject to:
breathing exposure to dust, mists, and fumes
skin exposure to oils and chemicals
COMPANY POSITION STATEMENT:
This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position. While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).
State or Province