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Senior Director of Operations

2 months ago

Huntsville, United States Discovery Life Sciences Full time

Position Summary:
DLS is looking for a talented and passionate Senior Director of Operations, Genomics to join our dynamic Genomics team. The Senior Director will play a key role within Discovery Life Sciences Clinical and Research Services by managing the operation of the genomics testing department, ensuring the highest quality data is generated, turnaround times are met, and budgetary guidelines are maintained. We offer an exciting and collaborative work environment where you can unleash your creativity and make a real impact.
 
A Day in the Life of a Senior Director of Operations, Genomics at Discovery Life Sciences:
• Responsible for supporting oversight of the laboratory departments operational acitives
• Ensures the laboratory management team adheres to written internal and external quality control.
• Guides the evaluation of means and standard deviations for quality control materials.
• Responsible for supporting oversight of the quality and timelines of technical procedures to ensure compliance with CAP/CLIA regulations, GCP/GCLP compliance.


Position Qualifications (Education, Skills, Experience):
• Ph.D. in Genomics, Molecular Biology, Immunology, or related discipline.
• ASCP certification preferred
• Minimum of 7 years of experience in a production genomics laboratory with a high level of leadership responsibility.
• Proficient in all relevant regulatory requirements for the biopharmaceutical industry (e.g., GCP/GCLP, 21 CFR Part 11, CAP/CLIA, HIPAA)
• Significant proven experience managing multiple tasks with good organization skills and good attention to detail.
• Ability to work as part of the team as well as set the example of performance standards for the team.
• Strong understanding of the use of biomarkers in clinical trials driving drug development.
• Ability to lead a team to work in conformance with standard operating procedure and conditions with a systematic approach to tasks committed to seeing things through to completion.
• Strong project management and organizational skills, with experience prioritizing and managing projects in a biopharma setting.
• Ability to identify and solve problems. Familiarity with laboratory methods and equipment with a demonstrated ability to ensure that data generated is within specifications and to troubleshoot any abnormalities.
• Ability to communicate effectively, both verbally and written with both biopharma clients and internal stakeholders.
• Strong organizational skills along with excellent oral and written communication ability
• Strong leadership and supervisory skills.
• Proficient user of windows-based computer programs including word processing, spreadsheet, data management (MS 365 products preferred)
• Knowledge of the principles of LEAN / Six Sigma is preferred.
• Familiarity with bioinformatics tools and pipelines specific to relevant clinical data and biopharma applications is preferred.

Key Responsibilities:
• Responsible for supporting Oversight of the laboratory department's operational activities within quality and budgetary guidelines, including oversight of continuous improvements and operational updates
• Responsible for high-level management of all Proficiency Testing programs within the guidelines of regulatory requirements and pertinent SOP's.
• Provides oversight for and guides the development, implementation, and management of performance standards for staff related to quality and efficiency, including productivity.
• Ensures the laboratory management team adheres to written internal and external quality control procedures in order to maintain the quality of results. Guides the evaluation of means and standard deviations for quality control materials and ensures the maintenance of corrective action logs as appropriate.
• Responsible for supporting oversight of the quality and timelines of technical procedures to ensure full compliance with CAP/CLIA regulations, GCP/GCLP compliance, and other relevant standards as determined by the company.
• Builds strong and effective teams, valuing different contributions; works with and through others, involving people in issues that affect them. Oversee the recruitment and selection of staff
• Liaise with clients, vendors and ILS or other Discovery staff on all department issues.
• Maintains oversight of reagent and supply orders and approval of inventory purchases. Working with the corporate procurement team, negotiates pricing and service requirements with Vendor representatives, supporting the best interests of Discovery. Ensures that the laboratory management team monitors reagents and supplies for section and assists in the performance of all related tasks for managing inventory.
• Identifies the key elements of a situation and any gaps and inconsistencies in data. Makes rational judgements from available information and analysis. Actively participates in root cause analysis investigations and process improvement initiatives.
• Responsible for timely and accurate responses to Quality Issues assigned to them and/or their department.
• Identifies development opportunities for self and others; Acts as a coach and mentor and shares expertise. Maintains a positive working environment ensuring staff motivation and engagement. Maintains low levels of staff turnover, actively contributing to the retention of key individuals
• Preparing reports by collecting, analyzing, and summarizing data to identify areas of improvement on identified issues
• Supports internal and external inspections by auditors
• Establish and track departmental goals and objectives that provide world-class quality and technical services performance to the organization.
• Follow company policies and procedures, including safety and/or universal precautions.
• Respect the privacy of the personal information of patients, co-workers, and all individuals with whom the Company interacts
• Ensure compliance with all laws and regulations applicable to the Company and its operations.
• Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
• Consistent and predictable attendance is an essential function of the position. Role is required on site at our Huntsville, AL, facility full-time.

Compensation and Benefits:
Discovery Life Sciences is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.

Your annual salary is only one part of your total compensation package. Other benefits:
• Competitive salary and benefits package options including free medical, dental, vision, life, and disability which start on your first day of employment. Free medical, dental and vision options for you and your Family members
• 401(k) match program which starts on your first day of employment
• Flexible work hours
• Time away from work (Generous vacation and paid time off, your BIRTHDAY, paid parental leave, paid family leave, etc.).
• Professional development opportunities and reimbursement for relevant certifications.
• Collaborative and inclusive work environment that values diversity.
• Team-building activities and social events.
• Employee Referral Program and Colleague Recognition Program

Location and work hours:
• Onsite, Huntsville, AL
• Flexible work schedule
• Up to 10% travel domestic or up to 5% international travel required for mandatory site meetings and trainings

We are actively seeking motivated, dedicated individuals like you to join our thriving organization. As a leader in our industry, we offer unparalleled opportunities for professional growth and success.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)