Client Operations Manager-Clean Rooms On-Demand (Pharma, Biotech, Med Device Operations Experience is a must)

Location: Burlington Cleanrooms On Demand
Department: Azzur Cleanrooms On Demand Burlington LLC

Job Description

 

Percentage

A

Act as client point-of-contact to support client on-site manufacturing operations.

50%

B

Develop client start-up and tech transfer strategies and manage their execution. Coordinate internal and external resource contributions to deliver projects to schedule and budget expectations.

25%

C

Help clients identify needs and build SOW proposals to provide services needed to assist the effective start-up, transition and daily support needed for client success.

15%

D

Coordinate with Internal Operations Manager to assure client service delivery to expectations.

 

10%

 

E

Work with Client and Accounting to accurate support the client invoicing process for the variable budget and tech transfer activities.

5%

Additional Functions:

1.      Functions of the job that are not essential, it may only occur twice a year for example.

1. Manage performance of reporting team members. Assist in career development. This is accomplished through developing team goals that are measurable to track team performance. Coach each team member to develop their skills which contribute to overall business unit success.

2. Contribute to compliance with regulations that are required to manage business and its practices. This is accomplished through supporting client audits, and contributing to quality change management events such as deviations, CAPA and change control events.

Behavioral Requirements:  (Add or remove as needed)

 [Some examples to include:]

·       Handling multiple responsibilities and job tasks (multi-tasking) as needed.

·       Demonstrating attention to detail.

·       Flexibility with work requirements, work environment and fast-paced/changing job needs.

 

Promoting teamwork by:

·       Collaborating with co-workers.

·       Attending staff meetings as required.

·       Meeting individual company goals as established.

·       Establishing rapport and maintaining positive communication with others, demonstrating respect and support, cooperating and flexibility with change.

·       Adhering to company and department policies.

Supervisory responsibilities of direct reports:

State whether or not this job has supervisory responsibilities.

[Delete this section if position does not have any direct reports. Leave section as is if position does have direct reports]

 

If supervisory responsibilities:

-        meets leadership goals by:

§  Planning, organizing and controlling all activities of the department in concert with the Leadership.

§  Lead at the site by with a positive and optimistic attitude, identifying team opportunities and coaching team members to achieve team and site goals.

§  Supports Leadership by establishing and communicating goals for direct reports.

§  Coaching, developing and motivating direct report/s to maximize performance & potential.

§  Provides regular periodic performance feedback and follows the company’s commitment to conduct and issue introductory reviews and Quarterly reviews as required.

§  Monitor set goals on a regular basis (quarterly).

 

-        meets Training & Development and HR goals, such as: 

·       Ensure adequate staffing levels are maintained

·       Identify and attract new staff

·       Participate in the training of new staff

·       Provide mechanism for professional growth and development of staff

·       Ensuring training has been received before undertaking specific duties and that all training is documented in training records as required by SOPs

·       Conforming to Company's Policies and Procedures

·       Ensuring accurate and timely completion of assigned employee timesheets

 

 

General Requirements:  (Don’t edit)

Maintains technical knowledge by attending educational workshops and/or reviewing publications.

Other duties as assigned by Sr. Management

Quality:

Adhere to all Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP).

Training & Development:

Ensure training has been received before undertaking specific duties and that all training is documented in training records.

Health & Safety:

Understand the company’s Health & Safety Policy and follow all associated procedures.  Report all accidents or awareness of any unsafe conditions in the workplace to management.

Human Resource Management:

Conform to the company’s policies contained in the Employee Handbook

Basic Qualifications & Position Requirements: (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. No one may be hired into a position if they do not meet the minimum requirements.)

Required Education:

·       Bachelor of Science degree from an accredited institution

 

Preferred Education:

·       Engineering degree from an accredited institution

 

Required Work Experience: 

·       Minimum of 3-5 years of experience in an operating company

 

Preferred experience:

·       5 years of experience in Facility Operations, Material Management and/or Tech Transfer Project Management in the Biopharm industry.

 

Required Knowledge:

·       Professional experience in a regulated industry

 

Preferred Knowledge:

·       Professional experience in the regulatory requirements and expectations of the Biopharmaceutical industry.

 

Skills (incl.Typical Mental Demands):

Reasoning Ability/Mathematical Skills/Computer Skills/Language Skills:

·       Strong written and verbal communication skills

·       Collaborative problem solving

 

Additional Qualifications:  [examples]

·       Customer service/client relations

·       Communication proficiency

·       Attention to detail

·       Can work productively independently with minor supervision

·       Self-motivated, flexible, dependable and available

·       Excellent organizational and time management skills

 

Work Environment & Dress attire: (The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, for example gowning/cleanroom requirements.)

 

Business Casual Office Environment

 

 

 

Physical Demands (The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Most positions require 10 lbs lifting requirement)

 

Lifting:

Weight Requirement

Moving/

Walking:

Number of Hours/Day

Sedentary:

Number of Hours/Day

Remain stationary:

Number of Hours/Day

Bending/

Reaching/

Twisting

(List Frequency; hrs./day)

Other

Equipment To Be Used:

(List Frequency)

Travel (frequency and/or percentage)

-local

-regional

-international

 

50 lbs.

 

6 hrs

 

2 hrs

 

2 hrs

 

4 hr

 

Computer, telephone

 

No travel expected

 

 

Reporting Structure: Reports to Vice President of Operations/Practice Leader

FLSA Status:    Exempt

 

Azzur will make reasonable accommodations to enable applicants to participate in the interview process and other aspects of the hiring process, as well as for employees working at Azzur, when we are aware of the need for such accommodations.

 

I understand that it is my responsibility to contact Human Resources if I need Azzur to consider making any accommodations to enable me to participate in the hiring process, including the interview, or for any of the job activities, duties or responsibilities included in this Job Description for any of the following reasons:

  1. Physical or mental health condition;
  2. Pregnancy or childbirth or medical conditions relating to the same; or
  3. Religious belief, practice or observance.

 

Azzur is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Azzur also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Azzur is an E-Verify employer.

 

Azzur is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

 

 



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