Sr Manager, Facilities Engineering

Overview

About the job
About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Sr. Manager, Facilities Engineering

YOU ARE more than just a title, YOU ARE… a strong leader with the ability to solve problems and develop good team relationships. You will Provide leadership in Facilities Maintenance & Calibration operations at Bioscience Laboratories Irvine and Lead all Maintenance & Calibration activities as well as support licensure of provision for BOTOX® Bulk Drug Substance materials and support Clinical Bulk Drug Substance supply for other pipeline neurotoxins.

You Will

Be a Strong Leader who will:

Support Technology Transfer, Engineering and Validation department activities required in the facility.

Support the Technology Transfer/Engineering teams to achieve their goals of a successful technology transfer, equipment and/or facility upgrades from schedule. Work on facility and utilities URS’s, Specifications, Documentation review and SOP generation.

Support the validation team strategy and timelines for the BLI facility & strategic projects. Provide support for facility and equipment validation, support external validation specialists as required, ensure proper training is received for the maintenance/calibration aspects of the facility and process equipment.

Facilities/Maintenance/Calibration Management

Manage the Facilities/Maintenance/Calibration functions, ensuring that the utilities and equipment perform efficiently and that spare parts are available as required.

Respond to breakdowns, emergencies, after hours calls.

Ensure that Maintenance & calibration effectively utilizes the SAP and/or RAM systems. Ensure that the PM requirements accurately reflect the needs of the facility/equipment to maintain them in Operational and cGMP condition.

Ensure that the Facilities/Maintenance team is technically competent in the operation, maintenance and faultfinding of all facilities and production utilities and equipment.

Effectively manage and implement Facility/Maintenance repairs, achieved within budgetary and time constraints. (Including shutdown works)

Collaborate and support EHS & Security policies and procedures to provide a safe working environment and compliance with regulatory authorities.

Set-up and maintain a calibrations system for all facilities and process related equipment. Ensure routine re-calibrations are conducted according to regulatory requirements and meeting required timelines

Regulatory Compliance And Validation

Adhere to the regulatory requirements as laid down by FDA, JP, EU MoH’s, Abbvie etc. All Facilities/Maintenance activities must meet AbbVie Regulatory, Quality Assurance and Validations requirements. Ensure that Regulatory, Corporate or Internal Audits generate no critical citations/observations relating to the Facilities/Maintenance & Calibration function.

Ensure that all maintenance & calibration activities are properly recorded and any equipment repairs and modifications are approved and documented in accordance with QA procedures.

Financial

Develop annual budgets for the Facilities and Maintenance function under Capital and Expense headings. Executes the budget and provide accurate, timely forecasts as required.

Manage the Spare parts stores for content and value accuracy.

Organizational Effectiveness

Ensures a competent Facilities/Maintenance work force is selected. Develop and maintain good working relationship with all functional areas in the company and facilitate a team based approach to meeting company objectives.

Manage the Facilities/Maintenance personnel and provide evaluation of their on-going performance and results. Implementation of the Company’s and Facilities/Maintenance Department’s policies, strategies and goals/objectives

Develop a Safety Culture Within The Group

Ensure that adequate training of maintenance personnel is carried out and correctly documented.

Strategic Planning And Development

Strategic planning is to be part of the daily activities to develop new and better ways to support the goals of the AbbVie organization. Thinking ‘out-of-the-box’ is to be support/facilitated.

Regulated Responsibilities (including CGMP And EHS)

AbbVie is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, EMA, OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.

Incumbent will work to ensure that the company is following all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.

Qualifications

Qualifications – External

You Bring

Degree or higher level qualification in an Engineering/Facilities/Maintenance discipline.
Experience in Facilities/Maintenance management position is a requirement.
Minimum of five years of experience/resp

La Jolla, CA, United States Lead Scientist, Organic/Medicinal Chemistry La Jolla CA 92093 United States Full Time 2021-02-06 10811_2234899 BioSpace No Science/R&D|Biotechnology|Chemistry Yes https://click.appcast.io/track/71tyysb-org?cs=izn&jg=2whx&bid=lUf2CslKyPxm6i440ZgUYA==Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into protein, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as smart cytokines to modulate the immune system, and long-acting therapeutic peptides for metabolic and cardiovascular disease. We are seeking a highly creative and motivated organic/medicinal chemist with project leadership skills to be a key member of dynamic research organization. The successful candidate will be part of a growing chemistry team who can contribute to discovering novel protein therapeutics to help patients in need.

Primary Responsibilities

The successful candidate will lead internal/external programs and cross-functional teams to execute

project plans

Lead our small molecule, linker, peptide design strategies and synthesis
Independently carryout structure-activity relationship studies and interpret experimental results to

propose new compound designs

Proven ability to initiate new programs and understanding of biology concepts to deliver proof-of-

concept data to make Go/No Go decisions

Proven ability to identify problems and propose solutions to move programs forward
Carryout analytical and preparative method development to support internal chemistry needs
Communicate research findings to the key stake holders and present in project meetings/conferences
Contribute to patent application writing and research reports
Identify and establish working relationships with CROs and manage external chemistry resources
Safe keeping and operation of lab and lab equipment

Qualifications

Ph.D. in organic/medicinal chemistry or related field with minimum 8-12 years of industry experience

as a Chemist

Must have experience working with antibody drug conjugates (ADCs) and understanding of ADC field
Proven track record in drug discovery project leadership and demonstrated success in Hit/Lead

identification and optimization and carrying out SAR studies

Experience in structure-based and pharmacophore-based drug designs
Experience in modern synthetic organic chemistry techniques, designing new synthetic routes for

biologically active molecules and carrying out multi-step synthesis in milligram to multi-gram scale

Hands-on experience with analytical and purification equipment HPLC, LC-MS and NMR etc.
Must have excellent presentation, written and verbal communication, organization, and collaborative

Skills

To be considered as an applicant, please submit your resume/CV referencing the specific position of interest and position code to careers@ambrx.com. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensation & benefits. yes
Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into protein, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as smart cytokines to modulate the immune system, and long-acting therapeutic peptides for metabolic and cardiovascular disease. We are seeking a highly creative and motivated organic/medicinal chemist with project leadership skills to be a key member of dynamic research organization. The successful candidate will be part of a growing chemistry team who can contribute to discovering novel protein therapeutics to help patients in need.

Primary Responsibilities

The successful candidate will lead internal/external programs and cross-functional teams to execute

project plans

Lead our small molecule, linker, peptide design strategies and synthesis
Independently carryout structure-activity relationship studies and interpret experimental results to

propose new compound designs

Proven ability to initiate new programs and understanding of biology concepts to deliver proof-of-

concept data to make Go/No Go decisions

Proven ability to identify problems and propose solutions to move programs forward
Carryout analytical and preparative method development to support internal chemistry needs
Communicate research findings to the key stake holders and present in project meetings/conferences
Contribute to patent application writing and research reports
Identify and establish working relationships with CROs and manage external chemistry resources
Safe keeping and operation of lab and lab equipment

Qualifications

Ph.D. in organic/medicinal chemistry or related field with minimum 8-12 years of industry experience

as a Chemist

Must have experience working with antibody drug conjugates (ADCs) and understanding of ADC field
Proven track record in drug discovery project leadership and demonstrated success in Hit/Lead

identification and optimization and carrying out SAR studies

Experience in structure-based and pharmacophore-based drug designs
Experience in modern synthetic organic chemistry techniques, designing new synthetic routes for

biologically active molecules and carrying out multi-step synthesis in milligram to multi-gram scale

Hands-on experience with analytical and purification equipment HPLC, LC-MS and NMR etc.
Must have excellent presentation, written and verbal communication, organization, and collaborative

Skills

To be considered as an applicant, please submit your resume/CV referencing the specific position of interest and position code to careers@ambrx.com. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensation & benefits.